FEBRUARY 2008
WEEK ENDING FEBRUARY 2
PRODUCT Biomet
Straight Magnum Inserter Handle, a preparatory instrument used for acetabular
component insertion; REF # or Catalog Number: S313141. (Systems affected by this
action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), CODE
Lots: 095112 and
474660
RECALLING FIRM/MANUFACTURERBiomet, Inc., Warsaw,
IN,
REASON Binding: The instrument was manufactured
incorrectly and its use may result in binding to the acetabular component and
cause the implant to not release following impaction.
VOLUME OF
PRODUCT IN COMMERCE 22
units
DISTRIBUTION Nationwide
PRODUCT AmniSure
ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model:
FMRT-1,
CODE Lot Number/ Exp. Date
A7003, 01/2009. A7002, 11/2008, A7001, 10/2008, A6005, 04/2008, A6004, 01/2008,
A6003, 09/2007, and A6002-3, 09/2007
RECALLING
FIRM/MANUFACTURER AmniSure International LLC, Cambridge, MA,
REASON
Weak true positive/false negative
results: weak true positive or false negatives in ruptured fetal membranes may
occur due to a "hook effect"
VOLUME OF PRODUCT IN
COMMERCE 170,000 kits
DISTRIBUTION Nationwide
and Internationally
PRODUCT Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an
in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs),
CODE
Lot Numbers: 49535M100 and
55451M200
RECALLING FIRM/MANUFACTURER Abbott
Laboratories, Abbott Park, IL
REASON Incorrect results: Reagents in
these lots were manufactured with an incorrect ratio of 2 key components, which
could result in both false reactive and false nonreactive
specimens.
VOLUME OF PRODUCT IN COMMERCE 1,722
packs
DISTRIBUTION Nationwide
PRODUCT Intuitive
Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da
Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and
420214-03,
CODE All instruments
manufactured till 03/21/07
RECALLING
FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA,
REASON
Mislabeling-electrical isolation
requirements: devices were incorrectly labeled with a CF symbol not their proper
BF Symbol on the instrument housing. (All instruments meeting the CF isolation
requirements are suitable for direct cardiac application, while instruments
meeting BF isolation requirements are not suitable for direct cardiac
application)
VOLUME OF PRODUCT IN COMMERCE 1,136
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Advanced
Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number
0070-1478,
CODE Serial Numbers:
75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391,
75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091,
76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111,
76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123,
76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033,
76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146,
76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032,
76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431,
75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126,
76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021,
76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163,
70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890,
75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037,
76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150,
76151, 76153, 76155, 76156, 76157, 76159, 76160,76162, 70272, 70280, 70297,
70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397,
75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439,
76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734,
76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864,
75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406,
75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005,
75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178,
76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060,
70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107,
70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440,
76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580,
70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072,
76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241,
70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and
76041
RECALLING FIRM/MANUFACTURER Visx, Inc., Santa
Clara, CA,
REASON Erroneous Treatment Calculations - Two software
caused errors; in combination, in the WaveScan System Software, will result in
an erroneous treatment calculation (overcorrection) in patients. (1)
Installation of software for a certain brand of computer (Dedicated Computing
LLC) can cause a software registry setting for an algorithm that identifies
image reflection to be erroneously set in the "off" position upon installation
on these specific computers, and (2) Software error in the WaveScan System
application produces erroneous treatment calculations.
VOLUME OF
PRODUCT IN COMMERCE 329
systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel, 135 Degree, 4H-92.6mm, sterile; REF 8315-35-004,
b) Depuy TK2 Compression Hip Screw trauma plate, Short Barrel,
135 DEG, 4H-92.6mm, sterile; REF 8315-35-104,
CODE
a) Lot: DHDB73;
b) Lot:
DHDB6P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy
Orthopaedics, Inc., Warsaw, IN,
Manufacturer: DePuy ACE S.a.R.L., Le Locle, Switzerland.
REASON
Mis-etched/labeled as to barrel
length: the lot with the short barrel was etched and labeled as a standard
barrel and the lot with the standard barrel was etched and labeled as a short
barrel.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION Nationwide
PRODUCT Oxy
Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6,
CODE
Lot 051101 - (Serial #'s: 001009,
001010, 001012, 001017, 001019, 001023, 001025, 001027, & 001029) -- Lot
05111 - (Serial #: 001049)-- Lot 051121 (Serial #'s: 001022, 001015, 001026,
530002, 530004, 001013, 001014, 001016, & 001034)-- Lot 051130 (Serial #'s:
530003, 001011, 001018, 001021, 001024, 001031, 001033, 001035, 001037, 001038,
001039, & 001050) -- Lot 051202 (Serial # 001044)-- Lot 063759 (Serial #'s:
001206, 001054, 001055, 001056, 001073, 001077, 001164, 001168, 001180, 001191,
001207, 001078, 001166, 001154, 001178, 001169, 001170, 001174, 001153, 001155,
001157, 001171, 001175, 001177, 001182, 001200, 001203, 001208, 001140, &
001165) Lot 063426 (Serial # 001093, 001101, 001111, 001128, 001106, 001114,
001076, 001112, 001074, 001084, 001092, 001124, 001126, 001134, 001137, 001141,
001142, 001167, 001069, 001057, 001099, 001130, 001135, 001150, 001118, 001139,
001075, 001052, 001117, 001119, 001176, 001061, 001053, 001103, 0011363, 001108,
001067, 001110, 001070, 001136, 001098, 001121, 001113, 001051, 001063, 001082,
001071, 001116, 001064, 001066, 001095, 001109, 001085, 001087, 001088, 001089,
001090, 001091, 001094, 001096, 001125, 001127, 001144, &
001145)
RECALLING FIRM/MANUFACTURER Superior Products,
Inc., Cleveland, OH,
REASON Leakage: Device was leaking
oxygen.
VOLUME OF PRODUCT IN COMMERCE 108
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No:
5773,
b) Terumo ultrasonic air
sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No:
5785,
c) Terumo Ultrasonic air
sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on
Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791,
CODE
a) Serial Numbers: 1988 through 4450,
4452 through 4457, 4459 through 4485, 4487 through 4500,
4502 through 4525, 4527 through 4545 and 4551;
b) Serial Numbers: 1106
through 1370 and 1376;
c) Serial Numbers: 1091 through
1307
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular
Systems Corp., Ann Arbor, MI,
REASON False Alarms: The air sensor
may malfunction and trigger false alarms, and may continue to alarm thus
preventing the device from being reset.
VOLUME OF PRODUCT IN
COMMERCE 2,826 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS,
b) Benchmark XT, Slide Staining
System, Catalog Number: N750-BMKXT-FS,
c) Benchmark LT, Slide Staining System, Catalog Number:
N750-BMKLT-FS,
d) Discovery,
Slide Staining System, Catalog Number: N750-DIS-FS,
e) Discovery XT, Slide Staining System, Catalog Number:
N750-DISXT-FS,
CODE
a) Serial Numbers: #810000-822654;
b)
Serial Numbers: #710000-711289;
c) Serial Numbers: #610000-610266;
d)
Serial Numbers: #810000-811666;
e) Serial Numbers:
#710000-711288
RECALLING FIRM/MANUFACTURER Ventana
Medical Systems, Inc., Tucson, AZ,
REASON Leaking Carboys/Safety Updates: The
Ventana Staining Platform includes one or more carboys that may have the
potential to leak if the spigot is either improperly installed or not fully
closed.
VOLUME OF PRODUCT IN COMMERCE 2,871
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length),
b) VNUS 7F ClosureFAST Catheter,
Order # ClF7-7-100 (100 cm working length),
CODE
a) Lot #s: 319484, 274119, 274900,
275146, 275637, 276054, 277311, 277775, 278742, 279181, 279614, 279880, 279938,
280314, 280315, 280316, 285851, 286800, 287108, 287566, 288293, 292135, 292432,
293002, 293275, 293276, 293830, 293832, 294657, 294881, 294882, 295263, 296973,
298603, 299607, 299929, 300573, 301032, 301354, 302329, 302628, 303250, 303712,
303723, 304640, 304698, 305533, 305894, 306571, 306834, 307366, 307561, 307938,
307951, 308465, 309081, 309441, 309741, 309782, 310338, 310401, 310408, 310920,
311185, 312220, 312241, 312334, 313084, 313104, 313373, 313530, 313792, 314079,
314241, 314548, 314655, 315253, 315389, 315751, 315765, 315913, 315922, 316405,
316652, 316653, 316947, 317041, 317342, 317421, 318802, 319117, and 319253;
b) Lot #s: 269157, 269653, 269937, 273326, 277761, 286201, 286565,
287746, 288012, 288336, 288984, 289027, 289757, 291483, 295539, 295786, 296215,
296218, 296974, 298602, 299406, 301347, 301352, 302596, 303252, 304271, 305063,
305550, 306673, 306823, 307368, 308780, 308782, 312677, 312735, 313529, 314828,
314829, 314829, 315084, 315381, 317485, 317827, 317889, 317972, 317979, 318124,
318259, 318556, and 318610
RECALLING
FIRM/MANUFACTURER VNUS Medical Technologies, Inc., San Jose, CA,
REASON
Instructions for Use change: Instructions
for Use have been changed to include a modified placement
recommendation.
VOLUME OF PRODUCT IN COMMERCE 22,937
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO,
b) ProTime Microcoagulation
System Instrument, Catalogue Number: PROTIMEPST,
c) ProTime Microcoagulation System Instrument: Catalogue Number:
PROTIMEINT,
CODE All instruments with Serial Number
V56560 or lower
RECALLING FIRM/MANUFACTURER
Recalling
Firm: International Technidyne Corp., Piscataway, NJ
Manufacturer: V Tech Communications Limited, Tai Po, Hong Kong.
REASON An increase in the
frequency of non-conformance reports (NCMR) for certain displayed error
messages.
VOLUME OF PRODUCT IN COMMERCE 5,910
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) ACAT
1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100,
b) AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog
No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535,
CODE
a) Serial Numbers: 070511A, 070512A,
070513A, 070514A, 070515A, 070516A, 070517A, 070518A, 070519A, 070520A, 070521A,
070522A, 070523A, 070524A, 070525A, 070601A, 070602A, 070603A, 070604A, 070605A,
10708A, 70206A, 70207A, 70208A, 70209A, 70210A, 70301A, 70302A, 70303A, 70304A,
70305A, 70401A, 70402A, 70403A, 70404A, 70405A, 70501A, 70502A, 70503A, 70504A,
70505A, 70506A, 70507A, 70508A, 70509A, 70510A, and 90305A;
b) Serial
Numbers: 070405V, 070411V, 070412V, 070413V, 070415V, 070416V, 070420V, 070421V,
070422V, 070423W, 070424V, 070426V, 070501V, 070502W, 070503W, 070510V, 070512W,
070513V, 070514W, 070518V, 070520W, 070522W, 070523W, 070524V, 070525W, 070526V,
070527V, 070528W, 070529V, 070530W, 070531W, 070532W, 070533W, 070534W, 070535W,
070536W, 070537V, 070538V, 070539V, 070540W, 070601W, 070602W, 070603V, 070604V,
070605W, 070606W, 070607W, 70608W, 070609W, 070610W, 070611W, 070612W, 070613W,
070614W, 070615W, 070616W, 070617W, 070618W, 070619W, 70620W, 070621W, 070622W,
070623W, 070624W, 070625W, 070626W, 070627W, 70628W, 070629W, 070630W, 070631W,
070632W, 070633W, 070634W, 070635W, 070636W, 070637W, 070638W, 070639W, 070640W,
070641W, 070642W, 070643W, 070644V, 070645W, 070646V, 070647V, 070648V, 070649W,
070650V, 31122V, 41146W, 51007W, 60930W, 60939W, 70111W, 70112W, 70113V, 70114W,
70115W, 70116V, 70117W, 70118W, 70119W, 70120W, 70121W, 70122W, 70123W, 70124V,
70125W, 70126V, 70127W, 70128V, 70129W, 70130W, 70131W, 70132W, 70133W, 70134W,
70135W, 70136W, 70137W, 70138W, 70139W, 70140W, 70141V, 70142W, 70143W, 70144W,
70145W, 70146W, 70147W, 70148W, 70149W, 70150W, 70201W,70202W, 70203W, 70204W,
70205W, 70206W, 70207W, 70208W, 70209W, 70210W, 70211W, 70212W, 70213W, 70214W,
70215W, 70216W, 70217W, 70218W, 70219W, 70220W, 70221V, 70222V, 70223W, 70224V,
70225W, 70226V, 70227W, 70228W, 70229V, 70230V, 70231W, 70232V, 70233W, 70234V,
70235V, 70236V, 70237W, 70238W, 70239W, 70240W, 70301W, 70302W, 70303W, 70304W,
70305W, 70306W, 70307W, 70308W, 70309W, 70310W, 70311W, 70312V, 70313W, 70314W,
70315V, 70316W, 70317W, 70318W, 70319V, 70320W, 70401W, 70402W, 70403W, 70404W,
70406W, 70407W, 70408W, 70409W, 70410W, 70414W, 70417W, 70418W, 70419W, 70425W,
70427W, 70428W, 70429W, 70430W, 70504W, 70505W, 70506V, 70507W, 70508W, 70509W,
70511W, 70515W, 70516W, 70517W, 70519W, and 70521V
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arrow International, Inc.,
Reading, PA,
Manufacturer: Arrow
International, Inc., Everett, MA.
REASON Leak may occur in the helium drive
system for the IABP.
VOLUME OF PRODUCT IN COMMERCE 272
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Abbott,
Accelerator Device Manager (ADM); List Number: 08H74-01,
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Irving,
TX,
Manufacturer: P.G.P. s.a., Brussels,
Belgium.
REASON Sample/Patient Mis-identification: Two
issues identified related to the ACCELERATOR Decision Manager (ADM), to include:
1) Sample Identification (SID) and/or Patient Identification (PID) numbers that
contain more than 12 characters are truncated to the final 12 characters by the
ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower
case characters are transmitted by the ADM as upper case characters. Both issues
have the potential for sample results to be associated with the incorrect
patient.
VOLUME OF PRODUCT IN COMMERCE 19
units
DISTRIBUTION Nationwide
PRODUCT AADCO
Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80
cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted
Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier,
E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm
Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted
Barrier with lamp,
CODE
Serial
Numbers: 03028006 03028007 03028008 03029004 03029005 03029011 03037001 03050001
03050002 03050006 03055001 03055002 03057030 03063006 03071001 03073001 03078007
03083043 03086001 03087023 03097003 03098001 03099001 03101001 03104001 03113001
03114001 03114002 03118001 03126002 03132001 03134001 03135002 03140001 03147002
03149002 03154001 03154001 03156004 03160003 03160004 03167003 03168002 03178001
03188001 03188003 03197001 03197002 03240002 03240003 03241001 03276004 03281001
03287001 03287002 03287003 03288003 03301007 03316001 03316002 03316003 03343006
03343010 03346001 03346002 03349001 03349002 03357003 03357004 03357005 03357006
03363001 04006001 04014004 04020001 04020003 04026001 04029001 04033001 04033003
04034001 04034003 04035001 04042001 04044001 04050001 04050002 04050003 04062001
04064001 04065001 04068001 04068002 04069003 04069006 04075001 04076001 04084125
04104001 04118001 04128001 04131001 04131002 04132001 04138001 04138002 04139001
04142001 04154002 04163001 04163002 04173005 04174001 04189001 04196001 04208001
04212002 04222001 04223001 04226003 04229001 04229004 04229006 04240001 04243001
04252001 04257001 04267001 04267002 04268001 04278001 04279001 04288001 04294005
04294007 04303001 04308001 04308003 04313001 04317001 04317002 04327001 04327002
04328004 04338001 04342001 04342002 04343002 04344001 04344004 04344011 04344012
04349001 04350006 04352001 04356002 04362005 04365001 04365002 05004001 05039001
05040003 05041004 05041005 05046001 05054002 05063009 05070001 05073002 05075001
05075003 05082004 05083002 05088003 05096001 05096002 06024006 06026001 06032001
06038001 06039001 06039002 06046003 06046004 06055004 06058001 06079001 06082001
06097001 06100001 06100002 06100003 06100005 06100006 06102003 06103001 06103002
06110001 06115001 06128001 06130001 06136001 06136002 06136003 06143003 06151001
06151002 06151004 06156001 06165002 06187003 06206001 06213001 06213002 06213003
06216004 06228001 06228003 06229003 06235001 06235002 06237002 06241001 06248001
06256002 06256005 06264001 06268001 06268003 06268004 06270002 06271001 06277002
06317001 06318001 06318004 06325001 06326002 06334001 06335004 06340002 07010004
07010005 07015001 07015002 07044001 07047003 07058001 07059001 07061001 07072001
07073001 07080001 07081011 07085002 07099001 07099002 07142001 07169001 07178002
07226001and 0727400 (not inclusive data goes back to 2003)
RECALLING
FIRM/MANUFACTURER Aadco Medical, Inc., Randolph, VT,
REASON
Screws may become loose from the mounted
shield compromising stability
VOLUME OF PRODUCT IN
COMMERCE 324 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Baxter
Single Day INFUSOR Portable Elastomeric Infusion System, Product Code:
2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case;
CODE
Lot Numbers: 07E037, 07E038, 07E039,
07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043,
07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074,
07J016, 07J018, 07J052, 07J054, and 07K020
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round
Lake, IL,
Manufacturer: Baxter
Healthcare Corporation, Medication Delivery Division, Irvine, CA.
REASON
Leaking: leaks at the
tubing flow restrictor connection to either the coupler or the male luer during
filling.
VOLUME OF PRODUCT IN COMMERCE 86,192
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
BD Vacutainer Push Button Blood collection sets with Pre-Attached
Holder; Catalog Number: 367352: 21G x 3/4" x 12"; 0.8 x
19mm x 305mm, Wingset PBBCS,
b)
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS
w/PAH
(Pre-attached),
CODE
a) Lot #’s: 7117874, 7157882, 7159943,
7180478, 7215299, 7215300, 7324340, and 7234341;
b)
Lot #'s: 6090251R, 6094839, 6111757R, 6121669, 6121676, 6138669, 6146186R, 6152710, 6151443, 6160625, 6164839, 6171015, 6174156,
6178381, 7018205, 7025868, 7026017, 7033728, 7093399,
7093400, 7093403, 7106969, 7106970,
7106971, 7106972,
7113647, 7113648, 7124156, 7124157, 7131786, 7141678,
7141679, 7141680, 7150272, 7162775, 7167155, 7169403, 7172215, 7177261, and 7208536
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company,
Franklin Lakes, NJ,
Manufacturer: BD
Preanalytical Solutions, Sumter, SC.
REASON Safety Mechanism Failure: the safety
mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached
holder cannot be activated; thus the needle cannot retract into the rear
barrel.
VOLUME OF PRODUCT IN COMMERCE 976,100
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Hoana
LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model
Number: 010135-01,
CODE All Serial
Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoana
Medical, Honolulu, Hawaii,
Manufacturer: Sanmina-SCI Corporation, San Jose, CA.
REASON
Bed Exit Failure: Failure to
recognize “Bed Exit” when the feature is active due to a software
anomaly.
VOLUME OF PRODUCT IN COMMERCE 216
units
DISTRIBUTION Nationwide
PRODUCT
a)
Tucker Embryo Catheter, Stylet, for use with Embryo Transfer Catheter, 23 cm, Sterile, Single Use Only, Order #: ftr 223,
b) Tucker Embryo Catheter,
Stylet, for use with Embryo Transfer
Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr
220,
c) Tucker Embryo Catheter with URM Tip, Embryo
Transfer Catheter, 20 cm, Order #: ftr120,
d) Tucker Embryo Catheter with URM Tip, Embryo Transfer
Catheter, 23 cm, Order #: ftr123,
e) Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #:
ftr320,
f) Morton IUI Catheter,
Sterile, Single Use Only, Order #: ftr510,
CODE All units shipped before August 17,
2007
RECALLING FIRM/MANUFACTURER Fertility Technology
Resources, Inc., Marietta, GA,
REASON Expiration Date for Sterility; The 5 year
dating could not be validated/supported for sterility
assurance.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide and
Internationally
PRODUCT Organogenesis
Apligraf, interactive wound and burn dressing,
CODE Lot Numbers: GS0711.20.01.2A and
GS0711.22.01.2A
RECALLING
FIRM/MANUFACTURER Organogenesis, Inc., Canton, MA,
REASON
Contamination:
Apligraf units were reported to have contamination in the agarose nutrient
medium of some units retained at Organogenesis. Preliminary tests show a gram
negative rod (bacillus) organism.
VOLUME OF PRODUCT IN
COMMERCE 177
units
DISTRIBUTION Nationwide
PRODUCT
a)
StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm,
b) StelKast Proven Knee - Tibial Half Block Augmentation and
Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm,
c) StelKast Proven Knee - Tibial Half Block
Augmentation and Screw. Part Number SC2287-3-5, Size 3,
Thickness 5 mm,
d) StelKast Proven Knee - Tibial Half
Block Augmentation and Screw.
Part Number SC2287-4-5,
Size 4, Thickness 5 mm,
e) StelKast Proven Knee -
Tibial Half Block Augmentation and Screw.
Part Number:
SC2287-5-5, Size 5, Thickness 5 mm,
CODE
a) Lot Numbers: 14888-122005,
16052-032706, and 18549-091807;
b) Lot Numbers: 14890-111605, 17084-110706,
and 17942-091807;
c) Lot Numbers: 14892-122005, 16156-032706, and
17943-091807;
d) Lot Numbers: 14894-122005, 16040-010906, 16054-031406,
17945-043007, and 17945-050107;
e) Lot Numbers:
14896-122005, 16042-010906, 16048-031406, 16056-031406, and 16157-031406
RECALLING
FIRM/MANUFACTURER StelKast Co., McMurray, PA
REASON
The screws may
fracture.
VOLUME OF PRODUCT IN COMMERCE 207
units
DISTRIBUTION Nationwide
PRODUCT Symphony
Staining System (High Volume Stainer), KPA, Model Number 2200000,
CODE
Lot #: 910044, 910020, 910041, 910060,
910038, 910008, 910048, 910029, 910057, 910006, 910027, 910049, 910036, 910011,
910014, 910056, 910022, 910019, 910016, 910046, 910042, 910007, 910053, 910031,
910021, 910037, 910077, 910032, 910023, 910028, 910034, 910054, 910025, 910045,
910001, 910002, 910015, 910017, 910018, 910026, 910030, 910043, 910004, 910024,
910003, 910047, PP-018, 910040, 910033, 910058, 910059, 910009, 910010, 910013,
PP-017
RECALLING FIRM/MANUFACTURER Ventana Medical
Systems Inc., Tucson, AZ
REASON Fluid Leaks-The T fitting
located in the Symphony Clear system of the Symphony High Volume Slide Stainer
needs to be larger to securely hold the tubing in place to eliminate any
possible fluid leak due to the tubing movement.
VOLUME OF PRODUCT IN
COMMERCE 55 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT 3M
ESPE Unitek Stainless Steel Permanent Molar Crowns, Product Code: 900321, Made
in U.S.A,
CODE Code Information: Lot
#: P060928
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M
Company / Medical Division, South St Paul, MN, Manufacturer: 3M Espe Dental Products, Irvine, CA.
REASON
Mislabeled:
Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which
incorrectly identified the product as Unitek Stainless Steel Primary Molar
Crowns.
VOLUME OF PRODUCT IN COMMERCE 975
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT AngioSculpt
PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5 mm x 10
mm,
CODE Lot number:
F07090015
RECALLING FIRM/MANUFACTURER AngioScore Inc.,
Fremont, CA,
REASON Mis-labeling: Product labeling on product
pouch indicates wrong size, the correct size is on the product
carton.
VOLUME OF PRODUCT IN COMMERCE 114
units
DISTRIBUTION Nationwide
WEEK ENDING FEBRUARY 9
PRODUCT
a)
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium
Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01,
3 mL Fill in a 12mL
Syringe, For Single Use only, Sterile
Solution Pathway, For IV Flush,
b) Sierra Pre-Filled, Heparin Lock Flush Solution
USP, 100
units/ml in 0.9% Sodium
Chloride 120/Case, Catalog
#1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL
Syringe,
For Single Use only, Sterile Solution Pathway, For IV Flush,
c) B. Braun, Heparin Lock Flush
Solution USP, 100 units/ml, 120/Case, Ref #513611,
NDC
#64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile
Solution Pathway, For IV Flush,
d) Braun, Heparin Lock Flush Solution
USP, 100 units/ml,
120/Case, Ref #513612,
NDC #64054-1003-02, 5 mL Fill in a
12mL Syringe, For Single Use only, Sterile
Solution
Pathway, For IV Flush,
e) Sierra Pre-Filled, Normal
Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2,
3
mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For
Single Use only, Sterile Solution Pathway, For IV Flush,
f) Sierra Pre-Filled, Normal Saline IV Flush, Catalog
#0905-12, NDC #64054-0905-2,
5 mL Fill in a 12mL Syringe,
0.9% Sodium Chloride Injection USP, 120/Case, For
Single
Use Only, Rx only, Sterile Solution Pathway, For IV Flush,
g) Sierra Pre-Filled, Normal Saline IV
Flush, Catalog #0910-12, NDC #64054-0910-2,
10 mL Fill in
a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For
Single Use only, Sterile Solution Pathway, For IV Flush,
h) B. Braun, Normal Saline IV Flush, REF #513584, NDC
64054-0903-2, 3 mL fill in a
12mL syringe, 120/Case,
Single Use Only, Rx Only,
i) B. Braun, Normal Saline IV
Flush, REF #513586, NDC 64054-0905-02, 5 mL fill in a
12mL
syringe, 120/Case, Single Use Only, Rx Only,
j) B.
Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a
12mL syringe, 120/Case, Single Use Only, Rx Only,
k) Sierra Pre-Filled, Heparin Lock Flush Solution
USP, 10
units/ml, Catalog #3005-02,
NDC #64054-3005-02, 5mL Fill
in a 12mL Syringe, 120/Case, For Single Use only,
Sterile
Solution Pathway, For IV Flush,
l) B. Braun, Heparin
Lock Flush Solution USP, 10 units/ml, Ref #513610, NDC #64054-
3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile
Solution
Pathway, For IV Flush
m) Sierra Pre-Filled, Heparin Lock Flush Solution
USP, 10
units/ml, Catalog #3003-02,
NDC #64054-3003-02, 3mL Fill
in a 12mL Syringe, 120/Case, For Single Use only,
Sterile
Solution Pathway, For IV Flush,
n) Sierra Pre-Filled,
Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06,
NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case,
For Single Use only,
Sterile Solution Pathway, For IV
Flush,
o) Sierra Pre-Filled, Heparin Lock Flush
Solution USP, 10 units/ml, Catalog #3005-06,
NDC
#64054-3005-06, 5mL Fill in a 6mL Syringe, 120/Case, For Single Use only,
Sterile Solution Pathway, For IV Flush,
CODE
All lots
RECALLING
FIRM/MANUFACTURER AM2 PAT Inc., Angier, NC,
REASON Lack of assurance of sterility by
manufacturer.
VOLUME OF PRODUCT IN COMMERCE 618
cases
DISTRIBUTION Nationwide
PRODUCT Philips
Page Writer Touch Cardiograph, Model: 860284,
CODE
Serial Numbers: US10603477 US60711180
US70711234 US80711276 US80711348 US80711386 US80711459 US10603478 US60711181
US70711235 US80711283 US80711349 US80711387 US80711460 US10603491 US60711182
US70711236 US80711284 US80711350 US80711388 US80711461 US10603493 US60711183
US70711241 US80711285 US80711351 US80711389 US80711462 US10603494 US60711184
US80503039 US80711286 US80711352 US80711390 US80711463 US10603495 US60711185
US80503049 US80711287 US80711353 US80711391 US90503082 US10603496 US60711186
US80711244 US80711288 US80711354 US80711392 US90503117 US10603497 US70711197
US80711245 US80711289 US80711355 US80711393 US90503119 US10603498 US70711199
US80711246 US80711290 US80711356 US80711394 US90503120 US10603499 US70711201
US80711247 US80711291 US80711357 US80711395 US90503121 US10603530 US70711205
US80711248 US80711292 US80711358 US80711396 US90503126 US10710463 US70711207
US80711249 US80711293 US80711359 US80711398 US90503127 US10710464 US70711208
US80711250 US80711294 US80711360 US80711399 US90503128 US10710465 US70711209
US80711251 US80711295 US80711361 US80711400 US90503129 US50502760 US70711210
US80711252 US80711296 US80711362 US80711402 US90503143 US50710968 US70711211
US80711253 US80711297 US80711363 US80711403 US90503148 US60502824 US70711212
US80711254 US80711298 US80711364 US80711404 US90503149 US60502825 US70711213
US80711255 US80711299 US80711365 US80711405 US90503150 US60502826 US70711214
US80711256 US80711300 US80711366 US80711406 US90503151 US60711064 US70711215
US80711257 US80711301 US80711367 US80711407 US90503152 US60711065 US70711216
US80711258 US80711302 US80711368 US80711408 US90503153 US60711067 US70711217
US80711259 US80711303 US80711369 US80711409 US90503154 US60711068 US70711218
US80711260 US80711304 US80711370 US80711411 US90503155 US60711070 US70711219
US80711261 US80711305 US80711371 US80711412 US90503156 US60711071 US70711220
US80711262 US80711306 US80711372 US80711413 US90503157 US60711073 US70711221
US80711263 US80711307 US80711373 US80711416 US90503158 US60711074 US70711222
US80711264 US80711308 US80711374 US80711417 US90503159 US60711075 US70711223
US80711265 US80711309 US80711375 US80711418 USD0301315 US60711076 US70711224
US80711266 US80711310 US80711376 US80711419 USD0610313 US60711077 US70711225
US80711267 US80711339 US80711377 US80711420 USN0301134 US60711078 US70711226
US80711268 US80711340 US80711378 US80711421 USN0400155 US60711079 US70711227
US80711269 US80711341 US80711379 US80711422 USN0402121 US60711080 US70711228
US80711270 US80711342 US80711380 US80711431 USN0402126 US60711081 US70711229
US80711271 US80711343 US80711381 US80711439 USN0402127 US60711176 US70711230
US80711272 US80711344 US80711382 US80711440 USN0402128 US60711177 US70711231
US80711273 US80711345 US80711383 US80711455 USN0402129 US60711178 US70711232
US80711274 US80711346 US80711384 US80711457 USN0610295 US60711179 US70711233
US80711275 US80711347 US80711385 US80711458 USO0610104
RECALLING
FIRM/MANUFACTURER Philips Medical Systems, Andover, MA,
REASON
Incorrect display: When using the 16 lead
Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the
extended lead modes of Pediatric and Balanced.
VOLUME OF PRODUCT IN
COMMERCE 266 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Siemans Simview 3000 Cassette Holder Electronic Imaging device (Image
Identifier),
with CT Part No: 19 57-161 or without CT
Part No. 19 57 153,
b) Siemans Simview NT Cassette
Holder Electronic Imaging Device (Image Identifier)
Part
No. 54 96 992,
c) Siemans Simview NT Cassette
Holder Electronic Imaging Device (Image Identifier)
with
CT, Part No: 54 96 984;
d) Siemans Simview NT Cassette
Holder Electronic Imaging Device (Image Identifier)
with
IDI, Part No: 54 97 016,
e) Siemans Mevasim, with
patient table, Part No: 44 81 586, and without patient table
Part No: 44-81-669,
CODE
a) Serial Numbers: 4164, 4062, 4114,
4037, 4155, 4125, 4180, 4096, 4064, 4107, 4145,
4144,
4143, 4081, 4172, 4152, 4090, 4161, 4181, 4093, 4066, 4054, 4091, 4068,
4128, 4179, 4019, 4023, 4117, 4094, 4015, 4083, 4174,
4074, 4082, 4011, 4078,
4034, 4063, 4025, 4171, 4086, ,
4134, 4029, 4002, 4003, 4004, 4027, 4053, 4061,
4118,
4123, 4124, 4008, 4009, 4010, 4014, 4016, 4017, 4021, 4022, 4024, 4026,
4031, 4032, 4035, 4043, 4059, 4072, 4075, 4076, 4078,
4085, 4087, 4092, 4095,
4098, 4102, 4104, 4105, 4108,
4109, 4110, 4111, 4112, 4115, 4116, 4130, 4136,
4142,
4150, 4153, 4156, 4173, 70001004511, 40000296842, 4099, 4147, 4100,
4154, 4044, 4119, 4121, 4122, 4131, 4139, 4185, 4020,
4030, 4036, 4079, 4135,
4167, 4077, 4039, 4071, 4120,
41514127, 4176, 4097, 4049, 4046, 4070, 4084,
4138, 4160,
4165, 4028, 4042, 4101, 410, 4158, 4045, 4065, 4060, 4088, 4177,
4073, 4113, 4175, 4141, 4040, 4137, and 4052;
b)
Serial Numbers: 6032, 6005, 6068, 6035, 6046, 6012, 6080, 6019, 6029, 6021,
6024, 6025, 6053, 6060, 6015, 6059, 6002, 6004, 6007,
6011, 6014, 6023, 6030,
6042, 6049, 6062, 4190, 6033,
6039, 6061, 6086, 6056, 6028, 3654, 6020, 6069,
6085,
6088, 6095, 6103, 6104, 6070, 6099-1, 6048, 6006, 1236, 6092, and 6054;
c)
Serial Numbers: 6013, 6003, 6078, and 6676;
d) Serial Numbers: 6018, 6001,
6008, 6067, 6037, 6038, 6059, 6041, 6047, 6017, 6027,
6036, 6040, 6050, 1256, 6082, 6056, 6064, 6083, 6034, 6044, 6055, 6058, 6028,
6090, 6105, 2255, 6079, 6089, 6073, 6052, 6077, 6072, and
6066
e) All Serial Numbers (1182 and higher): 1501, 1516, 1213, 1225, 1200,
1518, 1201,
1520, 1246, 1228, 1197, 1202, 1224, 1231,
1191, 1184, and 1506, "MEVASIM",
Serial Numbers (1182 and
higher): 1204, 1192, 1216, 1502, 1230, 1220, 1209, 1233,
1510, 1241, 1194, 1514, 1523, 1212, 1222, 1252, 2012, 2010-335-217, 1249,
4000296842, S1144, 01069H400, 1503, 1517, 1251, 1238,
1274, 1509, and 1519
RECALLING FIRM/MANUFACTURER Siemens
Medical Solutions USA, Inc., Concord, CA
REASON Loose Mounting Screws
-- Cassette holder may become loose and result in the device dislodging and
colliding with the patient.
VOLUME OF PRODUCT IN
COMMERCE 287 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic
imaging systems for fixed or mobile installations that
combine Positron Emission
Tomography (PET) and X-ray
Computed Tomography (CT) systems, Gemini TF
Product
Numbers/Manufacturer Numbers: TF 64 slice: 4535 679 94741, TF 16 slice:
4535 679 83931. Catalog Numbers: TF 64 slice: 882471, TF
16 slice: 882470,
b) Philips
Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems,
diagnostic imaging systems for fixed or mobile
installations that combine Positron
Emission Tomography
(PET) and X-ray Computed Tomography (CT) systems.
Gemini
GXL Product Numbers/Manufacturer Numbers: 16 slice: 4535 679 71891,
10 slice: 4535 679 75681, 6 slice: 4535 679 75691.
Catalog Numbers: 16 slice:
882410, 10 slice: 882400, 6
slice: 882390.
CODE
a) Serial
Numbers: 7001-7058, 7062, 7064, and 7066;
b) Serial Numbers:
4034-4159
RECALLING FIRM/MANUFACTURER Philips Medical
Systems (Cleveland) Inc., Cleveland, OH,
REASON Artifacts: Artifacts
may appear in some images from head scans on the CT subsystem of the GEMINI
PET/CT system. Reading images with these artifacts may lead to misdiagnosis or
improper treatment.
VOLUME OF PRODUCT IN COMMERCE 187
Systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT Hallmark
Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF #
62-3140,14mm; (The Hallmark Anterior Cervical Plate Systems consists of an
assortment of implantable titanium alloy plates and bone screws that are
provided non-sterile),
CODE All Lots
(Primary semi-contained rescue Screws: P/N's 62-3100 through 62-3180 and rescue
simi-constrained bone screws P/N's 62-4100- 62-4180)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blackstone Medical, Inc.,
Wayne, NJ,
Manufacturer:
Blackstone Medical Inc., Springfield, MA.
REASON Incomplete Design Validation: the laser
marking on the head of the screw lacked complete process
qualification
VOLUME OF PRODUCT IN COMMERCE 1,991
systems
DISTRIBUTION Nationwide
PRODUCT Vital
Images ViTALConnect, Version 4.0 and 4.1, PET/CT Visualization option. (A
web-based medical diagnostic tool that allows physicians to use PCs or notebook
computers to gain remote access to 2D, 3D, and 4D advanced visualization. The
software enables users to measure, rotate, and analyze images),
CODE
Versions 4.0 and 4.1 (PET/CT
Visualization option in VITALConnent)
RECALLING
FIRM/MANUFACTURER Vital Images, Inc., Plymouth, MN,
REASON
Standard Uptake Values (SUV)
display/update problems; in the way Standard Uptake Values (SUV) are displayed
in 3D/MPR views. The problem arises when a user draws a selected region of
interest in order to calculate the SUV statistics of the region. If the user
then changes the slice shown by scrolling through additional slices, the
original SUV measurements will remain on the screen and do not update with new
values for the current slice.
VOLUME OF PRODUCT IN
COMMERCE 18 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N:
9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage
12V, 7.5 amps;
b) life+cel,
Replacement battery for Cardiac Science FirstSave Survivalink; OEM
P/N: 9141-001, Part #: 2L561, Lithium Sulfur Dioxide,
Voltage 12V, 7.5 amps.,
CODE All Serial Numbers
RECALLING
FIRM/MANUFACTURER Exocomm Tech Group, Cumming, GA,
REASON
Marketed without a 510K
VOLUME
OF PRODUCT IN COMMERCE 266 batteries Part # 2L561; 46 batteries Part
# 7L877
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Baxter
RenalSoft v.2.0 Patient Management Software Suite - HD Module;
clinical data management software,
b) Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD
Module; clinical data
management software;
CODE
a) Serial Numbers 17023766 to
17026503;
b) All Serial Numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division,
McGraw Park, IL,
Manufacturer: Baxter
Healthcare Corporation, Largo, FL.
REASON Pre-Treatment/Post-Treatment Report
errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment
Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software
Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as
Administered on the Pre-Treatment report (RenalSoft v.2.0
only).
VOLUME OF PRODUCT IN COMMERCE 73
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Varian
Real-Time Position Management System (RPM), A Respiratory Gating System; Version
1.7.3, All Models,
CODE
Serial
Number: H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167,
H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131,
H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110,
H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002,
H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412,
H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214,
H502051, H502067, H500395, H500406, H500853, and H502066
RECALLING
FIRM/MANUFACTURER Varian Medical Systems, Inc., Palo Alto, CA,
REASON Erroneously Resetting: RPM System version 1.7.3,
software failure can occur that affects the gated radiotherapy treatment when
phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating
thresholds to system default during the treatment session, if the user accesses
the Session options during the treatment session. This can lead to difference
between the planned and delivered dose distribution for the treatment fraction
accepted.
VOLUME OF PRODUCT IN COMMERCE 59
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Ethicon
Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD,
CODE
Lot No:
D4HZ9Y
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Ethicon Endo-Surgery Inc., Cincinnati, OH,
Manufacturer: Ethicon Endo-Surgery, Inc.
S.A. de C.V. Planta II,
Ciudad Juarez, Chihuahua, Mexico.
REASON Sterility (package integrity) compromised;
damaged packaging may have compromised the sterility of the
devices.
VOLUME OF PRODUCT IN COMMERCE 2,844
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Datascope
CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump,
CODE
Serial Numbers: S805991-C2
S805993-C2 SA02504-C4 S806332-G2 S82934-H9 SA03941-F5 S82416-D9 S805969-C2
S806909-B3 S806924-B3 SA03395-A5 SA03407-A5 SI101373-H7 S805404-H1 S81758-K8
S807356-F3 S807013-C3 S806289-F2 S806308-G2 S806282-F2 S806306-G2 S806284-F2
S806292-F2 S806297-G2 SA04871-A6 S806286-F2 S806926-B3 S804246-J0 S805797-A2
S804934-D1 S806155-E2 SI101367-H7 SI100417-H7 S807506-J3 S807042-C3 S81471-I8
SA02801-G4 S8233778-E0 S82518-E9 S803467-B0 SA03469-B5 S806229-F2 S804255-J0
S806193-E2 S806025-D2 S806012-D2 S806019-D2 S806045-D2 S806017-D2 S806024-D2
S805992-C2 S806009-D2 S805581-I1 S82350-C9 S804783-B1 S804793-B1 S804799-B1
S806859-A3 SA01430-A4 SA01152-I3 SA01421-A4 SA01412-A4 S803857-F0 S803775-E0
SA02521-D4 SI01410-E7 S807446-G3 S807470-H3 S806225-F2 and S806259-F2 (These
serial numbers do not differentiate between CS100 and CS300, just the board
contained within.)
RECALLING FIRM/MANUFACTURER Datascope
Corp., Mahwah, NJ, .
REASON Defective Circuit Board -- A defect in
the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon
Pump may cause the pump to exhibit intermittent malfunctions, which include
failure to start-up or reset of the display screen during
therapy.
VOLUME OF PRODUCT IN COMMERCE 101
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01,
b) da Vinci S Surgical System 8
mm Long instrument cannula, Part #:420004-01,
c) da Vinci S Surgical System 5 mm instrument
cannula, Part #:
420011-01,
CODE
a) Lot umbers SA054701, SA055201, SA
060803, SA061001, SA061301, SA062001,
SA062502, SA62901,
SA063302;
b) Lot numbers SA054702, SA060504, SA062801, SA062104;
c) Lot #
SA061101
RECALLING FIRM/MANUFACTURER Intuitive Surgical,
Inc., Sunnyvale, CA,
REASON Devices may have a ridge on the side of
the cannula, which has the potential to abrade instrument shafts and generate
black particulate matter.
VOLUME OF PRODUCT IN
COMMERCE 896 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Spacelabs
Medical, Ultraview Multigas Analyzer, Model 91518,
CODE
1518-000511, 1518-000512, 1518-000080,
1518-000079, 1518-000078, 1518-000077, 1518-000074, 1518-000073, 1518-000071,
1518-000072, 1518-000028, 1518-000086, 1518-000083, 1518-000048, 1518-000015,
1518-000012, 1518-000011, 1518-000009, 1518-000065, 1518-000020, 1518-000022,
1518-000066, 1518-000068, 1518-000492, 1518-000473, 1518-000476, 1518-000483,
1518-000482, 1518-000481, 1518-000480, 1518-000479, 1518-000478, 1518-000477,
1518-000474, 1518-000467, 1518-000472, 1518-000471, 1518-000470, 1518-000469,
1518-000468, 1518-000475, 1518-000634, 1518-000562, 1518-000588, 1518-000589,
1518-000590, 1518-000591, 1518-000592, 1518-000593, 1518-000594, 1518-000595,
1518-000602, 1518-000603, 1518-000609, 1518-000610, 1518-000587, 1518-000597,
1518-000574, 1518-000584, 1518-000561, 1518-000564, 1518-000563, 1518-000565,
1518-000566, 1518-000573, 1518-000575, 1518-000576, 1518-000577, 1518-000578,
1518-000582, 1518-000583, 1518-000567, 1518-000145, 1518-000144, 1518-000143,
1518-000142, 1518-000281, 1518-000286, 1518-000282, 1518-000283, 1518-000278,
1518-000285, 1518-000277, 1518-000276, 1518-000275, 1518-000280, 1518-000521,
1518-000522, 1518-000598, 1518-000119, 1518-000664, 1518-000659, 1518-000660,
1518-000661, 1518-000662, 1518-000663, 1518-000665, 1518-000667, 1518-000668,
1518-000658, 1518-000669, 1518-000666, 1518-000656, 1518-000655, 1518-000654,
1518-000653, 1518-000650, 1518-000649, 1518-000648, 1518-000647, 1518-000645,
1518-000635, 1518-000633, 1518-000657, 1518-000713, 1518-000709, 1518-000714,
1518-000712, 1518-000711, 1518-000710, 1518-000707, 1518-000706, 1518-000705,
1518-000704, 1518-000703, 1518-000708, 1518-000039, 1518-000059, 1518-000056,
1518-000053, 1518-000052, 1518-000051, 1518-000049, 1518-000041, 1518-000032,
1518-000047, 1518-000254, 1518-000257, 1518-000263, 1518-000265, 1518-000272,
1518-000273, 1518-000220, 1518-000672, 1518-000623, 1518-000622, 1518-000632,
1518-000631, 1518-000630, 1518-000629, 1518-000627, 1518-000626, 1518-000624,
1518-000613, 1518-000621, 1518-000606, 1518-000612, 1518-000614, 1518-000617,
1518-000625, 1518-000619, 1518-000604, 1518-000620, 1518-000611, 1518-000445,
1518-000448, 1518-000447, 1518-000446, 1518-000267, 1518-000271, 1518-000227,
1518-000646, 1518-000682, 1518-000558, 1518-000559, 1518-000556, 1518-000557,
1518-000560, 1518-000382, 1518-000393, 1518-000384, 1518-000394, 1518-000383,
1518-000691, 1518-000689, 1518-000690, 1518-000308, 1518-000309, 1518-000179,
1518-000165, 1518-000174, 1518-000177, 1518-000178, 1518-000180, 1518-000182,
1518-000184, 1518-000185, 1518-000188, 1518-000173, 1518-000186, 1518-000170,
1518-000166, 1518-000167, 1518-000164, 1518-000163, 1518-000162, 1518-000161,
1518-000160, 1518-000159, 1518-000158, 1518-000171, 1518-000216, 1518-000335,
1518-000340, 1518-000341, 1518-000342, 1518-000343, 1518-000332, 1518-000358,
1518-000353, 1518-000517, 1518-000520, 1518-000518, 1518-000516, 1518-000509,
1518-000506, 1518-000508, 1518-000519, 1518-000507, 1518-000515, 1518-000168,
1518-000266, 1518-000268, 1518-000312, 1518-000310, 1518-000311, 1518-000386,
1518-000387, 1518-000388, 1518-000540, 1518-000542, 1518-000541, 1518-000535,
1518-000538, 1518-000536, 1518-000539, 1518-000537, 1518-000581, 1518-000579,
1518-000729, 1518-000730, 1518-000671, 1518-000670, 1518-000046, 1518-000084,
1518-000081, 1518-000076, 1518-000075, 1518-000055, 1518-000030, 1518-000067,
1518-000398, 1518-000451, 1518-000370, 1518-000375, 1518-000374, 1518-000373,
1518-000371, 1518-000369, 1518-000368, 1518-000367, 1518-000361, 1518-000359,
1518-000372, 1518-000360, 1518-000366, 1518-000362, 1518-000363, 1518-000364,
1518-000365, 1518-000427, 1518-000434, 1518-000457, 1518-000450, 1518-000454,
1518-000616, 1518-000157, 1518-000155, 1518-000156, 1518-000738, 1518-000743,
1518-000742, 1518-000741, 1518-000739, 1518-000737, 1518-000736, 1518-000735,
1518-000734, 1518-000733, 1518-000732, 1518-000740, 1518-000452, 1518-000453,
1518-000489, 1518-000596, 1518-000608, 1518-000599, 1518-000600, 1518-000247,
1518-000529, 1518-000534, 1518-000533, 1518-000532, 1518-000531, 1518-000528,
1518-000527, 1518-000526, 1518-000525, 1518-000524, 1518-000523, 1518-000530,
1518-000435, 1518-000436, 1518-000125, 1518-000129, 1518-000130, 1518-000132,
1518-000462, 1518-000336, 1518-000337, 1518-000510, 1518-000605, 1517-000605,
1518-000683, 1518-000684, 1518-000195, 1518-000206, 1518-000205, 1518-000181,
1518-000203, 1518-000207, 1518-000200, 1518-000199, 1518-000198, 1518-000197,
1518-000196, 1518-000194, 1518-000193, 1518-000192, 1518-000191, 1518-000190,
1518-000189, 1518-000183, 1518-000175, 1518-000172, 1518-000187, 1518-000301,
1518-000304, 1518-000303, 1518-000215, 1518-000319, 1518-000400, 1518-000376,
1518-000317, 1518-000318, 1518-000322, 1518-000323, 1518-000325, 1518-000035,
1518-000009, 1518-000485, 1518-000002, 1518-000035, 1518-000033, 1518-000005,
1518-000006, 1518-000023, 1518-000062, 1518-000235, 1518-000238, 1518-000234,
1518-000232, 1518-000233, 1518-000231, 1518-000243, 1518-000440, 1518-000449,
1518-000685, 1518-000328, 1518-000324, 1518-000219, 1518-000217, 1518-000218,
1518-000331, 1518-000333, 1518-000334, 1518-000403, 1518-000404, 1518-000406,
1518-000402, 1518-000442, 1518-000443, 1518-000493, 1518-000503, 1518-000504,
1518-000502, 1518-000651, 1518-000652, 1518-000720, 1518-000721, 1518-000464,
1518-000465, 1518-000466, 1518-000488, 1518-000057, 1518-000048, 1518-000636,
1518-000637, 1518-000120, 1518-000124, 1518-000123, 1518-000121, 1518-000122,
1518-000038, 1518-000040, 1518-000043, 1518-000044, 1518-000050, 1518-000036,
1518-000013, 1518-000045, 1518-000029, 1518-000024, 1518-000016, 1518-000008,
1518-000003, 1518-000034, 1518-000019, 1518-000349, 1518-000354, 1518-000355,
1518-000389, 1518-000397, 1518-000399, 1518-000110, 1518-000111, 1518-000380,
1518-000264, 1518-000293, 1518-000292, 1518-000294, 1518-000295, 1518-000296,
1518-000297, 1518-000356, 1518-000357, 1518-000225, 1518-000245, 1518-000226,
1518-000223, 1518-000222, 1518-000228, 1518-000113, 1518-000114, 1518-000385,
1518-000313, 1518-000314, 1518-000112, 1518-000105, 1518-000102, 1518-000103,
1518-000458, 1518-000459, 1518-000460, 1518-000461, 1518-000463, 1518-000007,
1518-000001, 1518-000063, 1518-000061, 1518-000069, 1518-000070, 1518-000099,
1518-000100, 1518-000101, 1518-000134, 1518-000135, 1518-000136, 1518-000137,
1518-000344, 1518-000345, 1518-000455, 1518-000456, 1518-000496, 1518-000497,
1518-000495, 1518-000699, 1518-000701, 1518-000700, 1518-000697, 1518-000696,
1518-000695, 1518-000698, 1518-000702, 1518-000126, 1518-000128, 1518-000484,
1518-000487, 1518-000486, 1518-000116, 1518-000117, 1518-000118, 1518-000291,
1518-000688, 1518-000692, 1518-000693, 1518-000694, 1518-000339, 1518-000543,
1518-000544, 1518-000545, 1518-000580, 1518-000585, 1518-000586, 1518-000601,
1518-000607, 1518-000133, 1518-000139, 1518-000140, 1518-000141, 1518-000726,
1518-000727, 1518-000444, 1518-000209, 1518-000210, 1518-000211, 1518-000213,
1518-000299, 1518-000437, 1518-000438, 1518-000439, 1518-000302, 1518-000115,
1518-000138, 1518-000298, 1518-000628, 1518-000131, 1518-000262, 1518-000244,
1518-000248, 1518-000249, 1518-000252, 1518-000253, 1518-000255, 1518-000256,
1518-000258, 1518-000259, 1518-000261, 1518-000270, 1518-000236, 1518-000242,
1518-000260, 1518-000202, 1518-000241, 1518-000201, 1518-000204, 1518-000208,
1518-000212, 1518-000214, 1518-000229, 1518-000239, 1518-000237, 1518-000169,
1518-000240, 1518-000224, 1518-000176, 1518-000441, 1518-000548, 1518-000505,
1518-000686, 1518-000715, 1518-000716, 1518-000717, 1518-000718, 1518-000719,
1518-000230, 1518-000221, 1518-000570, 1518-000379, 1518-000390, 1518-000377,
1518-000378, 1518-000391, 1518-000395, 1518-000251, 1518-000554, 1518-000127,
1518-000728, 1518-000305, 1518-000082, 1518-000104, 1518-000106, 1518-000107,
1518-000108, 1518-000109, 1518-000037, 1518-000042, 1518-000054, 1518-000085,
1518-000088, 1518-000745, 1518-000744, 1518-000426, 1518-000422, 1518-000423,
1518-000421, 1518-000424, 1518-000425, 1518-000428, 1518-000429, 1518-000430,
1518-000431, 1518-000433, 1518-000415, 1518-000420, 1518-000432, 1518-000408,
1518-000419, 1518-000417, 1518-000405, 1518-000409, 1518-000410, 1518-000411,
1518-000413, 1518-000414, 1518-000418, 1518-000401, 1518-000416, 1518-000396,
1518-000412, 1518-000017, 1518-000021, 1518-000290, 1518-000279, 1518-000284,
1518-000287, 1518-000288, 1518-000289, 1518-000615, 1518-000618, 1518-000572,
1518-000571, 1518-000641, 1518-000642, 1518-000643, 1518-000644, 1518-000640,
1518-000306, 1518-000568, 1518-000638, 1518-000639, 1518-000687, 1518-000553,
1518-000498, 1518-000499, 1518-000500, 1518-000246, 1518-000679, 1518-000680,
1518-000681, 1518-000678, 1518-000407, 1518-000307, 1518-000327, 1518-000316,
1518-000315, 1518-000676, 1518-000677, 1518-000673, 1518-000675, 1518-000674,
1518-000330, 1518-000731, 1518-000346, 1518-000352, 1518-000351, 1518-000350,
1518-000347, 1518-000348, 1518-000546, 1518-000547, 1518-000549, 1518-000550,
1518-000551, 1518-000552, 1518-000555, 1518-000513, 1518-000514, 1518-000097,
1518-000098, 1518-000320, 1518-000321, 1518-000326, 1518-000329, 1518-000250,
1518-000269, 1518-000300, 1518-000746, 1518-000747, 1518-000748, 1518-000749,
1518-000750, 1518-000751, 1518-000150, 1518-000153, 1518-000151, 1518-000154,
1518-000149, 1518-000148, 1518-000147, 1518-000146, and
1518-000152
RECALLING FIRM/MANUFACTURER Spacelabs
Healthcare, Inc., Issaquah, WA
REASON Inaccurate partial pressure readings;
readings are not compensated for ambient pressure in mmHg or kPa.
VOLUME OF PRODUCT IN COMMERCE
722
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Intuitive
brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02,
CODE
Lot Numbers Affected: SA070902,
SA071101, and SA071401
RECALLING
FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA,
REASON
Sharp Edges: the 5mm Cannula may have a
sharp edge on the inner diameter of the Cannula. The defective cannula may cause
particulate shavings to be skive (scraping) from the instrument shafts during
surgery.
VOLUME OF PRODUCT IN COMMERCE 89
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system
consists of an a monoplane positioner, a vascular or
cardiac table, an X-ray system
and a digital detector),
b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging
System, (The system consists of
an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital
detector),
c) GE Innova 4100 /
4100 IQ. , (The system consists of an a monoplane positioner, a
vascular or cardiac table, an X-ray system and a
digital detector),
CODE
a) 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01
0850060723 DZ1006VA01 0910162009 0910162010 0910162011 0910162012 0910163011
0910163014 0910162013 010120RX44 0002673668 604875AINNOVA1 416480INNOVA
604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 082416100014 082416150002
082416100011 082416130026 082416010005 082416010007 082416030005 082416040011
082416040012 082416040014 082416050003 082416060001 082416070006 082416100009
082416100012 082416100017 082416120008 082416130016 082416130019 082416130023
082416130024 082416160007 082416180003 082416200004 082416210007 082416220010
082416120009 2664023INNOVA CS1118VA03 CS1006VA04 FI1017VA02 FI1017VA03
FI1025VA01 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529
M4176519 M4183841 M4200108 M4211066 M4496941 B4192944 M2621511 HC4348XR02
PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 00060VAS02 00159VAS04
00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03
00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01
00197VAS01 H2077VAS27 0828160007 0002644132 08301600206936 083016002101586
083016102100795 083016202101036 083016202101917 083016242100936 083016282101457
083016602101386 083016802100516 083016802100866 083016802100916 083016862101407
083016862101656 083016862101916 83016802100337 83016862100377 083016602101807
083016802101197 "08301680520687 (temp 0002673438)" 083016822101187 0835160017
0835160018 IE1100VA02 A5333036 A5333037 A147111802 A5125125 A5129025 A5131858
A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506
A5807919 A58080104 B5120723 B5219603 C5123625 C5123626 C5323515 A5624127 YV0053
YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066
YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077
YV0078 YV0079 YV0080 YV0081 YV0100 KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03
LV4000VA02 LV4000VA03 LV4001VA02 LT4000VA04 0002679402 0002684003X 644INNOVA21
83INNOVA2588441 MA1004VA02 NO1009VA03 600151VA01 600042VA03 PER00218 0002674834
787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 SA1011VA01 SA1054VA02 0847160002
0847160003 FEB52055 ME612436 CEE15663 SD1038VA01 A004RX01 A020RX13 468668XR01
SY1001VA02 SY2005VA01 0853060191 853060197 06052VAS01 20001VAS02 34009VAS06
34134VAS02 35049VAS01 58010VAS01 80002VAS01 505848CATH1 505848EP 318448INNOVA3
305682IN2 4105502100 410554INNOVA2 208367INNOVA 208381CCL1 2035762100
717217CA10002 843797TCL1 214947MINNOVA 214947MINNOVA2 PRESBYDEP 303839CL2
252384CATH1 303788CL1 4436432100 4107872100 8184092100 864255SFCL2 219932DCL2
305364P2100 954987CL4 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1
8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 608775NOVA2 0002507622
310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2
0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4 212305CATH1
212604INNOVA1 65049321 304424INNOVA 610983INNOVA2 201447LAB1 215453INNOVA21
253627INNOVA1 229228INNOV21C 8053702100 RPINNOVA2100 303425CL3 305682IN2X
317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 336538ARCL1 360456XCL4
405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA
417347FCV4 423495MCATH1 501257VALAB1 508335CA1 508856IN21 509575YM2100
516562INNOVA2A 518243LAB1 518243LAB2 561548ET2 570476INNOVA21 573761SMC2
573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 608775NOVA1
610250INNOVA1 610250INNOVA3 610776INNOVA21 612273INNOVA2 615284CV3 615342CV3
615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2
706291CLIN1 713375U2100 713375UCA 717217INN21 717544GECATH2 717544GECATH3
718470EP 718780CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1
781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1
813615CL8 813615CL9 813615EP3 814452EP 815741CA1000 815759CARDIAC1 817329BG2100
843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100
858554INNOVA2 858554INNOVA3 864255SFCL1 904597CATH 910343EP1 910343EP2
910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8
970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F
FHOMEP 508941IN21 508335INNOVA 843692CATH3 828213IN21 901765EP 410554INNOVA4 and
410554INNOVA3;
b) HU1099VA04 0850060719 0850060724 0850060726 0850060727
0850060728 378INV31 0910064009 0910163012 0910163013 0910163015 BE5003VA02
140024RX09 BA4080VA01 2573329 2667313 BG4549VA02 082416040018 082416140004
082416290001 082416140003 082416130018 082416080001 082416010006 082416020004
082416020005 082416030006 082416040015 082416040019 082416100013 082416110002
082416110003 082416120010 082416140002 082416150001 082416160008 082416160009
082416160013 082416180004 082416190004 082416190001 082416190002 082416190003
082416210006 082416210008 082416220008 082416270002 082416300001 082416310003
082416310006 082449100050 082416160011 082416160012 082416170002 082416040017
082416070004 2625365INNOVA 2645993INNOVA CS1006VA03 0002655786 M2030709 M4163030
M4166988 M5480755 M6083613 A6017504 GE1005VA01 HC4348XR01 HC1536XR04 00203VAS01
01367VAS02 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001
B5810907 YV0036 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039
YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 KW1055VA01
0834160003 83INNOVA1188379 0920169007 2048000INNOVA 2664627INNOVA PL1082VA01
600098VA01 RU2457VA01 RU1482VA02 RU1475VA01 RU1550VA01 MPX82206 FPG86403
FPG93008 DPM32143 DPN88402 0853060194 01012VAS01 41018VAS01 58002VAS01
60001VAS01 215576INNOVA1 518525LAB1 760242CATH1 404686CRI3 4103623100
281420LAB23100 541382CV3 205783BCL5 540953INNOVA 2035763100 508941IN1
717217INN31 843797TCL2 573815BCR1 361980INNOVA2 214590PH3100 313593IC2
561266IN31 303629CL4 303629EP 3027443100 7018573100 303788CL2 812450EP1
239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV
305364P3100 205877CCL1 808547QCV2A 281440CL3 208227CATH2 2014183100 7028533100
865693CCL1 765453INNOVA1 609757IN3100 6619483100 219326IN31 7022333100
816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100
215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1
812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100
850469BCV1 8508573100 ECXV1406C 413447CATH BPINNOVA3R 207662CL4 207879CL131
770991CL3 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 417269SCLD
7278253100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 8019643100
303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1
316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2
405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100
414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7
417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100
516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31
573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31
610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2
631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA
717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1
772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3
815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4
856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA
910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1
973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA
718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2
405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3
610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1
2036883100 and 388567772VASMET;
c) 0850060718 0850060720 0850060721
0850060722 0850060725 514842AINNOVA 613548INNOVA3 082406070010 082406310005
082416030007 082416040020 082416100016 082416130020 082416130021 082416130025
082416220006 FI1015VA02 M1230007 HC0220XR07 00490VAS02 01278VAS01 10091VAS01
083006202101017 IE1100VA01 IL1043VA01 A5102671 A5163317 A5605732 XF0150 XF0151
XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 KW1001VA03
KW1001VA04 KW1018VA04 LB1037VA01 600042VA02 600152VA01 RU2714VA01 RU2992VA01
RU1050VA03 SA1005VA06 0002603739 0002603828 3184734100 706774USP3 6309784100
6616324100 304256INNOVA 2035764100 352596SPEC 423495MSPEC2 5135844100
719560INN41 303320OR41 303399IR 303436ANGIO 3027444100 574294IN41 804594CATH
239939INNOVA 574535IN41 252847PRS3 864255SF4100 305823IN4100 7137764100
3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 304424CCINOVA 309655FSP1A
4134474100 5033704100 509474SH41 813745INTV 813972INTV 201541SP1 229228INNOV41V
281401T4100 918744JR4100 22925941V2 586573SP1 SHOWCASE4100 508856OR41
314569SJRM12 314966DPHSP 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1
386254HS2 386HPOS1 404466SF41A 404GHSIR1 410337INNOVA2 412647OR10 414649DVI
419696LAB1 505848CATH2 505848V4100 508650IN41 509482HFI 512901NI4100
530888ANG206 541686SPR1 561548VAS2 570321LAB2 605333RM10 610988INNOVA4 617636IN1
619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1
706291RINN2 706651SP1 706733SP1 708783CL4100 708783SP4100 713375U4100
718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41
812825INNOVA1 813615CL10 815740SC4100 817465AR4100 817922BA4100 843577CL2
845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1
915577SP1 918682IN41 954MW4100 970247INNOVA COR359867 DR4100 FHORL4100
PEMBROKE4100 RADNETXV1 RHD4100 480512SP 8458584100 770736SP1 423495M4100E
423493I4100 8593134100 313343SP1 708202VA41 708WESTSUB4100 and 509575YM4100
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE
Healthcare, Waukesha, WI,
Manufacturer: GE
Medical Systems, SCS, Buc Cedex, France.
REASON Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became
"frozen" on the DL (digital leader acquisition system) live monitor screen. In
such cases, the system continued to send out X-rays without reporting an error
message. The result was that the live imaging screen displayed an older "frozen"
image until the operator released the pedal. During an intervention, an operator
could be misled to believe that the "frozen" image is instead a live dynamic
image. This translates to an inability to see/control stent, endo-prosthesis
placement, glue injection, or other device placement during an intervention and
thus an increased patient risk of catheter, guidewire, glue an/or device
misplacement.
VOLUME OF PRODUCT IN COMMERCE 868
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232,
b) Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234,
CODE
a) Lot Number: 448530;
b)
Lot Number: 448740
RECALLING FIRM/MANUFACTURER Biomet,
Inc., Warsaw, IN,
REASON Mislabeled as to size: Package labeled as
containing a 67 mm tray actually contains a 75 mm tray and vice
versa.
VOLUME OF PRODUCT IN COMMERCE 16
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper
Applier F/Mini Ti-Clipsstr 146 mm,
b) Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #:
FT430T, Casper
Applier F/Std Ti-Clipsstr 146 mm,
CODE
a) Part #: FT420T;
b) Part #:
FT430T
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Aesculap Inc., Center Valley, PA,
Manufacturer: Aesculap AG & Co. KG,
Tuttlingen, Germany.
REASON Breakage: the inner
rod of the applier may corrode and break
VOLUME OF PRODUCT IN
COMMERCE 144 clips
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
Number: 00-AG087312, .035/300cm, stiff/angled/standard,
sold as a single hydrophilic
guidewire in both sterile
and bulk non-sterile packaging configurations,
b) Argon Medical Devices, ArgoGuide Hydrophilic NiTi
Guidewire,
K011905, Catalog
Number: 00-AG387307, .035/150cm,
stiff/straight/standard, sold as a single
hydrophilic
guidewire in both sterile and bulk non-sterile packaging configurations,
c) Argon Medical Devices,
ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
Number: 00-AG387308, .035/180cm, stiff/straight/standard, sold as a single
hydrophilic guidewire in both sterile and bulk
non-sterile packaging configurations,
d) Argon Medical Devices, ArgoGuide Hydrophilic NiTi
Guidewire,
K011905, Catalog
Number: 00-AG387309, .035/300cm,
stiff/straight/standard, sold as a single
hydrophilic
guidewire in both sterile and bulk non-sterile packaging configurations,
e) Argon Medical Devices,
ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single
hydrophilic
guidewire in both sterile and bulk
non-sterile packaging configurations,
f) Argon Medical Devices, ArgoGuide Hydrophilic NiTi
Guidewire,
K011905, Catalog
Number: 00-AG387311, .035/180cm,
stiff/angled/standard, sold as a single hydrophilic
guidewire in both sterile and bulk non-sterile packaging configurations,
g) Argon Medical Devices, ArgoGuide
Hydrophilic NiTi Guidewire, K011905, Catalog
Number:
00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic
guidewire in both sterile and bulk non-sterile packaging
configurations,
h) Argon Medical
Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
Number: 00-AG387319, .038/150cm, stiff/straight/standard, sold as a single
hydrophilic guidewire in both sterile and bulk
non-sterile packaging configurations,
i) Argon Medical Devices, ArgoGuide Hydrophilic NiTi
Guidewire, K011905, Catalog
Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single
hydrophilic guidewire in both sterile and bulk
non-sterile packaging configurations,
j) Argon Medical Devices, ArgoGuide Hydrophilic NiTi
Guidewire, K011905,
Catalog
Number: 00-AG387324, .038/300cm,
stiff/angled/standard, sold as a single
hydrophilic
guidewire in both sterile and bulk non-sterile packaging configurations,
CODE
a) Lot
Numbers: 99513867, 99508829, and 99508830;
b) Lot Numbers:
99508645, 99497398, and 99535020;
c) Lot Numbers: 99502708,
and 99510894;
d) Lot Numbers:
99496751;
e) Lot Numbers: 99504912, 99509169, and
99534483;
f) Lot Numbers: 99504955, 99496794, and
99537348;
g) Lot Numbers: 99505290, 99504749, and
99525828;
h) Lot Number: 99503850;
i) Lot Number: 99504098;
j) Lot
Number: 99504587
RECALLING FIRM/MANUFACTURER Argon
Medical Devices, Inc., Athens, TX,
REASON Degradation --
Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing
particulate to dislodge potentially resulting in embolism.
VOLUME OF
PRODUCT IN COMMERCE 2,861
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are
single
lumen catheters with a single proximal hub for
attachment to a dye delivery system.
Catalog No.
16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4,
PIG 145. 100 and 110 cm Length. Made in Mexico,
b) Boston Scientific, Impulse Angiographic Catheter, Sterile
EO.
Catheters are single
lumen catheters with a single
proximal hub for attachment to a dye delivery system.
Catalog No. 16599-89. 6F AR MOD (Single Pack). Distal curve AR MOD. 100 cm
length,
c) Boston Scientific,
Impulse Angiographic Catheter, Sterile EO. Catheters are single
lumen catheters with a single proximal hub for attachment to a dye
delivery system.
Catalog No. 16599-04. 6F FR6 (5-pack).
Distal curve FR6. 100 cm length,
d) Boston Scientific, Impulse Angiographic Catheter, Sterile
EO. Catheters
are single
lumen catheters with a single proximal hub for
attachment to a dye delivery system.
Catalog No.
16599-195. 6F LCB (5-pack). Distal curve LCB. 100 cm length,
e) Boston Scientific, Impulse
Angiographic Catheter, Sterile EO. Catheters are single
lumen catheters with a single proximal hub for attachment to a dye delivery
system.
Catalog No. 16599-202. 6F IM T (t-pack). Distal
curve IM T. 100 cm length,
f)
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are
single
lumen catheters with a single proximal hub for
attachment to a dye delivery system.
Catalog No.
16599-86. 6F AR2 (5-pack). Distal curve AR2. 100 cm length,
g) Boston Scientific, Impulse
Angiographic Catheter, Sterile EO. Catheters are single
lumen catheters with a single proximal hub for attachment to a dye delivery
system.
Catalog No. 16599-201. 6F IM (5-pack). Distal
curve IM. 100 cm length,
h)
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are
single
lumen catheters with a single proximal hub for
attachment to a dye delivery system.
Catalog No.
16599-302. 6F MULTI PIG 155 (5-pack). Distal curve FL4, FR4, PIG
155. 100 and 110 cm length,
i)
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are
single
lumen catheters with a single proximal hub for
attachment to a dye delivery system.
Catalog No.
16599-98. 6F AL2 (5-pack). Distal curve AL2. 100 cm length,
j) Boston Scientific, Impulse
Angiographic Catheter, Sterile EO. Catheters are single
lumen catheters with a single proximal hub for attachment to a dye
delivery system.
Catalog No. 16599-01. 6F FR3.5 (5-pack).
Distal curve FR3.5. 100 cm,
k)
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are
single
lumen catheters with a single proximal hub for
attachment to a dye delivery system.
Catalog No.
16599-03. 6F FR5 (5-pack). Distal curve FR5. 100 cm length,
CODE
a) Catalog
No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.
16599-
301/H749165993010/H749165993010/0020032538 and
16599-
301/H749165993010/H749165993010/002003517;
b) Catalog No./outer box Material
No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-89/H74916599890/H74916599890/0020032541;
c) Catalog No./outer box
Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-04/H74916599042/H74916599040/0020033644; and 16599-
04/H74916599042/H74916599040/0020036932;
d) Catalog No./outer box Material
No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-195/H749165991952/H749165991950/0020033662;
e) Catalog No./outer box
Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-202/H749165992022/H749165992020/0020033665;
f) Catalog No./outer box
Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-86/H74916599862/H74916599860/0020033690;
g) Catalog No./outer box
Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-201/H749165992012/H749165992010/0020035115;
h) Catalog No./outer box
Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-302/H749165993022/H749165993020/0020035141;
i)
Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-98/H74916599982/H74916599980/0020035149
j)
Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-01/H74916599012/H74916599010/0020036925;
k)
Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
16599-03/H74916599032/H74916599030/0020036931
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston ScientificMaple Grove, MN,
Manufacturer: Pacific Device De Mexico S A
De C V, Tijuana B C Mexico.
REASON Flash may be protruding from the lumen of the
catheter shaft. If this flash is present in the catheter, there is the potential
of an embolization resulting from the flash detaching from the device during the
procedure.
VOLUME OF PRODUCT IN COMMERCE 211 single
units
DISTRIBUTION Nationwide
PRODUCT
a)
Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator,
Plasma Resistant Fiber [PRF], (both Model 541T),
b) Medtronic Blood Collection Reservoir, 40 micron,
Catalog/Model # EL240,
CODE
a) Lot Numbers: 8870107 and 8851934;
b) Lot Numbers: 8763774, 8763791 and 8763782
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems,
Brooklyn Park, MN,
Manufacturer: Medtronic
Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico.
REASON
Unapproved Component Resin:
Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Auto transfusion
Blood Collection Reservoirs contain components made from an unapproved
resin
VOLUME OF PRODUCT IN COMMERCE 447
units
DISTRIBUTION Nationwide
PRODUCT Cyberonics,
VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld
and preprogrammed with software v7.1 and higher,
CODE All Model 250 units using Dell x5 handheld
computers.
RECALLING FIRM/MANUFACTURER Cyberonics, Inc.,
Houston, TX,
REASON Screen Freezes-- The Dell X5
Handheld PC screen will freeze caused due to incompatibility between the
Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the
handheld device becomes non-responsive to user input.
VOLUME OF
PRODUCT IN COMMERCE 6,642
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037,
b) Smiths Medical, Add-On Kids
Kit , Blood Sampling System, Product Code: MX4033,
CODE a) and b) Lot Numbers: 1189082,
1231444, 1178100, and 1225588
RECALLING
FIRM/MANUFACTURER Smiths Medical Asd, Inc., Dublin, OH,
REASON
Misbranded. The product codes are labeled
incorrectly with a green promotional label for "New split septum sampling site.
Only use needle-free access devices .......", however this product code contains
a sampling site which is accessed with a shrouded needle, NOT with a needle-free
access device.
VOLUME OF PRODUCT IN COMMERCE 1,690
kits
DISTRIBUTION Nationwide
Chattem Issues URGENT Nationwide Recall of Icy Hot® Heat Therapy™ Products
Chattem, Inc. is initiating a Nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz. Aspercreme® product. This recall is being conducted to the consumer level.
Chattem is recalling these products because it has received some consumer reports of first, second and third degree burns as well as skin irritation resulting from consumer use or possible misuse of these products.
All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:
NOTE: if products have been removed from their holding cartons the recalled products are packaged in a red colored plastic pouch which states Icy Hot Heat Therapy and either Back or Arm/Neck and Leg.
Single consumer use "samples" of Icy Hot Heat Therapy- Arm, Neck and Leg were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as "Icy Hot Heat Therapy Air Activated Heat," with their own internal labeling.
These products are sold over the counter through food, drug and mass merchandisers.
Consumers who have the Icy Hot Heat Therapy products under recall should immediately stop using the products, discard them, and/or return them to Chattem, Inc.
Product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-888-458-3487 (M-F from 8am to 4pm EST) or via our website at http://www.chattem.com/.
This recall only involves the above listed Icy Hot Heat Therapy products including single consumer use "samples" that were included in cartons of 3 oz. Aspercreme Pain Relieving Crème and does not involve any other Icy Hot or Aspercreme products.
Consumers with questions or concerns about this product may contact Chattem’s Consumer Affairs Department at 1-888-442-4464 (M-F 8am to 4pm EST).
WEEK ENDING FEBRUARY 16
PRODUCT
a)
Medtronic SynchroMed EL Programmable Pump, Model 8626-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the
SynchroMed EL Infusion System designed to contain and
administer parenteral drugs to a specific site),
b) Medtronic SynchroMed EL Programmable Pump, Model 8626L-10.
(The implantable Medtronic SynchroMed EL Programmable
Pump is part of the SynchroMed EL Infusion System
designed to contain and administer parenteral drugs to a specific site),
c) Medtronic SynchroMed EL
Programmable Pump, Model 8626-18. (The implantable
Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer
parenteral drugs to a specific site),
d) Medtronic SynchroMed EL Programmable Pump, Model 8626L-18.
(The implantable Medtronic SynchroMed EL Programmable
Pump is part to a specific site),
e) Medtronic SynchroMed EL Programmable Pump, Model
8627-10. (The implantable Medtronic SynchroMed EL
Programmable Pump is part of the SynchroMed EL Infusion
System designed to contain and administer parenteral drugs to a specific site),
f) Medtronic SynchroMed EL
Programmable Pump, Model 8627L-10. (The implantable
Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed
EL Infusion System designed to contain
and administer parenteral drugs to a specific site),
g) Medtronic SynchroMed EL
Programmable Pump, Model 8627-18. (The implantable
Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer
parenteral drugs to a specific site)
h)
Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the
SynchroMed EL Infusion System designed to contain and
administer parenteral drugs to a specific site),
CODE
a) thru h): Serial Numbers: For recalls Z-0739-0746-2008; NGA000015R, NGA000017R, NGA000018R, NGA000020R, NGA000021R, NGA000022R, NGA000024R, NGA000025R, NGA000028R, NGA000034R, NGA000036R, NGA000037R, NGA000038R, NGA000040R, NGA000041R, NGA000042R, NGA000043R, NGA000051R, NGA000052R, NGA000053R, NGA000055R, NGA000056R, NGA000057R, NGA000058R, NGA000059R, NGA000061R, NGA000062R, NGA000066R, NGA000067R, NGA000071R, NGA000072R, NGA000074R, NGA000075R, NGA000076R, NGA000077R, NGA000078R, NGA000090R, NGA000100R, NGA000105R, NGA000125R, NGA000132R, NGA000136R, NGA000140R, NGA000144R, NGA000151R, NGA000159R, NGA000161R, NGA000161R, NGA000173R, NGA000174R, NGA000175R, NGA000176R, NGA000176R, NGA000177R, NGA000179R, NGA000180R, NGA000183R, NGA000186R, NGA000188R, NGA000190R, NGA000191R, NGA000192R, NGA000193R, NGA000195R, NGA000197R, NGA000199R, NGA000201R, NGA000202R, NGA000210R, NGA000211R, NGA000220R, NGA000221R, NGA000222R, NGA000223R, NGA000226R, NGA000234R, NGA000235R, NGA000237R, NGA000238R, NGA000241R, NGA000241R, NGA000246R, NGA000247R, NGA000249R, NGA000250R, NGA000254R, NGA000255R, NGA000257R, NGA000261R, NGA000263R, NGA000266R, NGA000267R, NGA000268R, NGA000269R, NGA000271R, NGA000272R, NGA000273R, NGA000275R, NGA000276R, NGA000277R, NGA000278R, NGA000279R, NGA000280R, NGA000281R, NGA000282R, NGA000293R, NGA000295R, NGA000296R, NGA000297R, NGA000298R, NGA000299R, NGA000300R, NGA000301R, NGA000302R, NGA000303R, NGA000304R, NGA000305R, NGA000306R, NGA000336R, NGA000338R, NGA000343R, NGA000344R, NGA000345R, NGA000346R, NGA000347R, NGA000348R, NGA000349R, NGA000351R, NGA000352R, NGA000357R, NGA000366R, NGA000372R, NGA000373R, NGB000008R, NGB000009R, NGB000011R, NGB000012R, NGB000013R, NGB000014R, NGB000015R, NGB000017R, NGB000018R, NGB000020R, NGB000021R, NGB000022R, NGB000023R, NGB000024R, NGB000025R, NGB000026R, NGB000027R, NGB000028R, NGB000029R, NGB000030R, NGB000031R, NGB000034R, NGB000035R, NGB000037R, NGB000038R, NGB000039R, NGB000040R, NGB000041R, NGB000042R, NGB000043R, NGB000044R, NGB000045R, NGB000046R, NGB000047R, NGB000048R, NGB000049R, NGB000050R, NGB000051R, NGB000052R, NGB000053R, NGB000054R, NGB000055R, NGB000056R, NGB000057R, NGB000058R, NGB000059R, NGB000060R, NGB000061R, NGB000062R, NGB000063R, NGB000064R, NGB000065R, NGB000066R, NGB000067R, NGB000068R, NGB000069R, NGB000072R, NGB000073R, NGB000074R, NGB000075R, NGB000076R, NGB000078R, NGB000079R, NGB000080R, NGB000081R, NGB000082R, NGB000083R, NGB000084R, NGB000085R, NGB000087R, NGB000088R, NGB000089R, NGB000090R, NGB000091R, NGB000093R, NGB000095R, NGB000096R, NGB000098R, NGB000099R, NGB000100R, NGB000102R, NGB000103R, NGB000105R, NGB000106R, NGB000107R, NGB000108R, NGB000110R, NGB000111R, NGB000113R, NGB000114R, NGB000115R, NGB000116R, NGB000117R, NGB000118R, NGB000119R, NGB000122R, NGB000123R, NGB000124R, NGB000125R, NGB000126R, NGB000127R, NGB000128R, NGB000129R, NGB000130R, NGB000131R, NGB000133R, NGB000134R, NGB000135R, NGB000136R, NGB000137R, NGB000138R, NGB000139R, NGB000140R, NGB000141R, NGB000142R, NGB000143R, NGB000144R, NGB000145R, NGB000146R, NGB000147R, NGB000148R, NGB000149R, NGB000150R, NGB000152R, NGB000153R, NGB000154R, NGB000157R, NGB000158R, NGB000159R, NGB000160R, NGB000161R, NGB000162R, NGB000163R, NGB000164R, NGB000165R, NGB000166R, NGB000167R, NGB000168R, NGB000169R, NGB000170R, NGB000171R, NGB000172R, NGB000173R, NGB000174R, NGB000175R, NGB000176R, NGB000191R, NGB000193R, NGB000195R, NGB000196R, NGB000198R, NGB000199R, NGB000204R, NGB000205R, NGB000205R, NGB000207R, NGB000208R, NGB000210R, NGB000210R, NGB000216R, NGB000217R, NGB000219R, NGB000221R, NGB000222R, NGB000223R, NGB000224R, NGB000225R, NGB000228R, NGB000229R, NGB000230R, NGB000231R, NGB000234R, NGB000236R, NGB000236R, NGB000238R, NGB000239R, NGB000240R, NGB000241R, NGB000246R, NGB000247R, NGB000248R, NGB000254R, NGB000255R, NGB000256R, NGB000257R, NGB000259R, NGB000261R, NGB000262R, NGB000267R, NGB000268R, NGB000269R, NGB000270R, NGB000273R, NGB000275R, NGB000278R, NGB000279R, NGB000280R, NGB000284R, NGB000289R, NGB000292R, NGB000292R, NGB000294R, NGB000295R, NGB000302R, NGB000303R, NGB000311R, NGB000313R, NGB000315R, NGB000318R, NGB000318R, NGB000319R, NGB000323R, NGB000324R, NGB000325R, NGB000326R, NGB000327R, NGB000329R, NGB000330R, NGB000333R, NGB000334R, NGB000335R, NGB000336R, NGB000337R, NGB000338R, NGB000339R, NGB000340R, NGB000341R, NGB000344R, NGB000345R, NGB000347R, NGB000349R, NGB000350R, NGB000350R, NGB000367R, NGB000372R, NGB000377R, NGB000377R, NGB000378R, NGB000382R, NGB000383R, NGB000386R, NGB000387R, NGB000388R, NGB000389R, NGB000390R, NGB000391R, NGB000392R, NGB000395R, NGB000396R, NGB000397R, NGB000398R, NGB000400R, NGB000401R, NGB000402R, NGB000402R, NGB000403R, NGB000406R, NGB000408R, NGB000409R, NGB000410R, NGB000411R, NGB000412R, NGB000415R, NGB000416R, NGB000417R, NGB000419R, NGB000420R, NGB000422R, NGB000425R, NGB000426R, NGB000427R, NGB000428R, NGB000431R, NGB000432R, NGB000433R, NGB000439R, NGB000440R, NGB000447R, NGB000448R, NGB000450R, NGB000451R, NGB000452R, NGB000453R, NGB000454R, NGB000456R, NGB000458R, NGB000460R, NGB000461R, NGB000462R, NGB000463R, NGB000465R, NGB000471R, NGB000475R, NGB000477R, NGB000479R, NGB000480R, NGB000481R, NGB000482R, NGB000483R, NGB000484R, NGB000485R, NGB000486R, NGB000488R, NGB000490R, NGB000491R, NGB000493R, NGB000495R, NGB000496R, NGB000497R, NGB000499R, NGB000502R, NGB000507R, NGB000508R, NGB000509R, NGB000510R, NGB000511R, NGB000519R, NGB000523R, NGB000526R, NGB000528R, NGB000530R, NGB000531R, NGB000531R, NGB000532R, NGB000535R, NGB000536R, NGB000538R, NGB000538R, NGB000538R, NGB000538R, NGB000538R, NGB000538R, NGB000539R, NGB000544R, NGB000545R, NGB000547R, NGB000548R, NGB000549R, NGB000550R, NGB000551R, NGB000552R, NGB000553R, NGB000557R, NGB000559R, NGB000560R, NGB000563R, NGB000565R, NGB000567R, NGB000568R, NGB000569R, NGB000570R, NGB000571R, NGB000572R, NGB000573R, NGB000575R, NGB000575R, NGB000576R, NGB000578R, NGB000579R, NGB000582R, NGB000585R, NGB000586R, NGB000587R, NGB000588R, NGB000592R, NGB000592R, NGB000596R, NGB000600R, NGB000601R, NGB000602R, NGB000603R, NGB000604R, NGB000605R, NGB000606R, NGB000607R, NGB000610R, NGB000613R, NGB000623R, NGB000627R, NGB000628R, NGB000633R, NGB000633R, NGB000640R, NGB000643R, NGB000647R, NGB000652R, NGB000653R, NGB000654R, NGB000655R, NGB000656R, NGB000657R, NGB000661R, NGB000665R, NGB000666R, NGB000667R, NGB000668R, NGB000669R, NGB000672R, NGB000673R, NGB000674R, NGB000675R, NGB000676R, NGB000679R, NGB000680R, NGB000681R, NGB000684R, NGB000685R, NGB000686R, NGB000687R, NGB000688R, NGB000689R, NGB000690R, NGB000695R, NGB000697R, NGB000701R, NGB000702R, NGB000705R, NGB000706R, NGB000707R, NGB000708R, NGB000709R, NGB000711R, NGB000714R, NGB000715R, NGB000718R, NGB000720R, NGB000722R, NGB000723R, NGB000724R, NGB000726R, NGB000727R, NGB000728R, NGB000730R, NGB000732R, NGB000733R, NGB000734R, NGB000736R, NGB000738R, NGB000739R, NGB000741R, NGB000742R, NGB000743R, NGB000745R, NGB000746R, NGB000747R, NGB000748R, NGB000749R, NGB000751R, NGB000752R, NGB000753R, NGB000754R, NGB000755R, NGB000756R, NGB000757R, NGB000758R, NGB000759R, NGB000760R, NGB000761R, NGB000762R, NGB000763R, NGB000767R, NGB000768R, NGB000771R, NGB000772R, NGB000773R, NGB000773R, NGB000774R, NGB000776R, NGB000776R, NGB000777R, NGB000777R, NGB000778R, NGB000782R, NGB000783R, NGB000785R, NGB000786R, NGB000787R, NGB000795R, NGB000797R, NGB000803R, NGB000805R, NGB000808R, NGB000812R, NGB000814R, NGB000816R, NGB000818R, NGB000820R, NGB000822R, NGB000822R, NGB000824R, NGB000826R, NGB000827R, NGB000828R, NGB000829R, NGB000830R, NGB000831R, NGB000832R, NGB000833R, NGB000834R, NGB000835R, NGB000836R, NGB000837R, NGB000838R, NGB000839R, NGB000840R, NGB000841R, NGB000842R, NGB000843R, NGB000844R, NGB000845R, NGB000846R, NGB000847R, NGB000848R, NGB000851R, NGB000855R, NGB000857R, NGB000860R, NGB000862R, NGB000864R, NGB000866R, NGB000867R, NGB000871R, NGB000874R, NGB000879R, NGB000883R, NGB000884R, NGB000886R, NGB000887R, NGB000888R, NGB000889R, NGB000890R, NGB000893R, NGB000895R, NGB000896R, NGB000897R, NGB000902R, NGB000906R, NGB000906R, NGB000908R, NGB000910R, NGB000911R, NGB000918R, NGB000919R, NGB000927R, NGB000930R, NGB000931R, NGB000934R, NGB000936R, NGB000940R, NGB000944R, NGB000945R, NGB000946R, NGB000947R, NGB000948R, NGB000953R, NGB000954R, NGB000958R, NGB000959R, NGB000961R, NGB000963R, NGB000964R, NGB000965R, NGB000967R, NGB000970R, NGB000971R, NGB000974R, NGB000980R, NGB000980R, NGB000981R, NGB000985R, NGB000986R, NGB000990R, NGB000997R, NGB000998R, NGB000998R, NGB001008R, NGB001011R, NGB001013R, NGB001014R, NGB001017R, NGB001018R, NGB001019R, NGB001020R, NGB001021R, NGB001035R, NGB001036R, NGB001037R, NGB001037R, NGB001043R, NGB001044R, NGB001048R, NGB001049R, NGB001050R, NGB001052R, NGB001053R, NGB001054R, NGB001055R, NGB001056R, NGB001057R, NGB001059R, NGB001060R, NGB001061R, NGB001062R, NGB001063R, NGB001064R, NGB001066R, NGB001068R, NGB001070R, NGB001071R, NGB001074R, NGB001075R, NGB001077R, NGB001078R, NGB001079R, NGB001080R, NGB001081R, NGB001082R, NGB001083R, NGB001084R, NGB001085R, NGB001086R, NGB001089R, NGB001090R, NGB001091R, NGB001092R, NGB001093R, NGB001095R, NGB001108R, NGB001109R, NGB001111R, NGB001112R, NGB001113R, NGB001114R, NGB001115R, NGB001116R, NGB001117R, NGB001118R, NGB001119R, NGB001120R, NGB001121R, NGB001123R, NGB001124R, NGB001125R, NGB001126R, NGB001127R, NGB001128R, NGB001129R, NGB001130R, NGB001131R, NGB001133R, NGB001135R, NGB001139R, NGB001140R, NGB001141R, NGB001146R, NGB001149R, NGB001150R, NGB001152R, NGB001154R, NGB001158R, NGB001160R, NGB001162R, NGB001163R, NGB001166R, NGB001167R, NGB001172R, NGB001176R, NGB001176R, NGB001177R, NGB001179R, NGB001181R, NGB001182R, NGB001183R, NGB001185R, NGB001186R, NGB001187R, NGB001188R, NGB001191R, NGB001192R, NGB001193R, NGB001194R, NGB001195R, NGB001196R, NGB001197R, NGB001198R, NGB001199R, NGB001200R, NGB001201R, NGB001202R, NGB001203R, NGB001204R, NGB001205R, NGB001206R, NGB001207R, NGB001208R, NGB001209R, NGB001210R, NGB001211R, NGB001212R, NGB001214R, NGB001215R, NGB001217R, NGB001219R, NGB001220R, NGB001222R, NGB001223R, NGB001224R, NGB001225R, NGB001226R, NGB001227R, NGB001228R, NGB001229R, NGB001230R, NGB001231R, NGB001232R, NGB001234R, NGB001235R, NGB001236R, NGB001237R, NGB001238R, NGB001240R, NGB001242R, NGB001246R, NGB001248R, NGB001249R, NGB001250R, NGB001251R, NGB001253R, NGB001255R, NGB001257R, NGB001260R, NGB001261R, NGB001263R, NGB001265R, NGB001266R, NGB001267R, NGB001268R, NGB001269R, NGB001277R, NGB001278R, NGB001281R, NGB001284R, NGB001285R, NGB001287R, NGB001291R, NGB001293R, NGB001295R, NGB001296R, NGB001297R, NGB001299R, NGB001301R, NGB001302R, NGB001303R, NGB001304R, NGB001306R, NGB001307R, NGB001308R, NGB001310R, NGB001316R, NGB001317R, NGB001317R, NGB001320R, NGB001321R, NGB001323R, NGB001324R, NGB001324R, NGB001325R, NGB001325R, NGB001327R, NGB001328R, NGB001333R, NGB001336R, NGB001337R, NGB001338R, NGB001341R, NGB001341R, NGB001342R, NGB001345R, NGB001346R, NGB001347R, NGB001347R, NGB001348R, NGB001349R, NGB001351R, NGB001355R, NGB001356R, NGB001357R, NGB001358R, NGB001359R, NGB001359R, NGB001360R, NGB001361R, NGB001362R, NGB001363R, NGB001364R, NGB001365R, NGB001366R, NGB001367R, NGB001368R, NGB001369R, NGB001370R, NGB001371R, NGB001382R, NGB001384R, NGB001385R, NGB001389R, NGB001392R, NGB001395R, NGB001396R, NGB001397R, NGB001398R, NGB001399R, NGB001400R, NGB001401R, NGB001402R, NGB001403R, NGB001404R, NGB001405R, NGB001407R, NGB001408R, NGB001410R, NGB001411R, NGB001413R, NGB001414R, NGB001415R, NGB001417R, NGB001419R, NGB001421R, NGB001422R, NGB001423R, NGB001424R, NGB001424R, NGB001425R, NGB001426R, NGB001427R, NGB001428R, NGB001429R, NGB001430R, NGB001431R, NGB001432R, NGB001433R, NGB001434R, NGB001435R, NGB001436R, NGB001437R, NGB001438R, NGB001439R, NGB001440R, NGB001441R, NGB001442R, NGB001445R, NGB001446R, NGB001446R, NGB001460R, NGB001462R, NGB001465R, NGB001470R, NGB001471R, NGB001472R, NGB001473R, NGB001474R, NGB001475R, NGB001478R, NGB001480R, NGB001482R, NGB001484R, NGB001485R, NGB001489R, NGB001490R, NGB001491R, NGB001492R, NGB001493R, NGB001494R, NGB001495R, NGB001496R, NGB001498R, NGB001499R, NGB001500R, NGB001501R, NGB001502R, NGB001503R, NGB001504R, NGB001505R, NGB001506R, NGB001507R, NGB001508R, NGB001509R, NGB001510R, NGB001511R, NGB001512R, NGB001513R, NGB001514R, NGB001523R, NGB001524R, NGB001524R, NGB001525R, NGB001526R, NGB001528R, NGB001529R, NGB001530R, NGB001531R, NGB001531R, NGB001532R, NGB001536R, NGB001539R, NGB001540R, NGB001542R, NGB001544R, NGB001545R, NGB001548R, NGB001549R, NGB001551R, NGB001554R, NGB001555R, NGB001556R, NGB001559R, NGB001560R, NGB001562R, NGB001563R, NGB001564R, NGB001565R, NGB001566R, NGB001567R, NGB001568R, NGB001569R, NGB001570R, NGB001571R, NGB001572R, NGB001573R, NGB001574R, NGB001575R, NGB001576R, NGB001577R, NGB001578R, NGB001579R, NGB001580R, NGB001581R, NGB001583R, NGB001585R, NGB001586R, NGB001587R, NGB001588R, NGB001589R, NGB001590R, NGB001591R, NGB001592R, NGB001593R, NGB001594R, NGB001595R, NGB001596R, NGB001597R, NGB001598R, NGB001599R, NGB001600R, NGB001601R, NGB001602R, NGB001603R, NGB001604R, NGB001605R, NGB001606R, NGB001607R, NGB001608R, NGB001610R, NGB001611R, NGB001612R, NGB001613R, NGB001615R, NGB001616R, NGB001617R, NGB001618R, NGB001619R, NGB001620R, NGB001621R, NGB001622R, NGB001623R, NGB001624R, NGB001625R, NGB001626R, NGB001627R, NGB001628R, NGB001630R, NGB001631R, NGB001632R, NGB001634R, NGB001635R, NGB001636R, NGB001638R, NGB001640R, NGB001641R, NGB001642R, NGB001643R, NGB001645R, NGB001647R, NGB001648R, NGB001649R, NGB001650R, NGB001651R, NGB001652R, NGB001654R, NGB001655R, NGB001656R, NGB001657R, NGB001658R, NGB001659R, NGB001660R, NGB001661R, NGB001662R, NGB001663R, NGB001665R, NGB001666R, NGB001668R, NGB001670R, NGB001671R, NGB001672R, NGB001673R, NGB001674R, NGB001675R, NGB001676R, NGB001677R, NGB001678R, NGB001679R, NGB001680R, NGB001681R, NGB001682R, NGB001684R, NGB001685R, NGB001687R, NGB001688R, NGB001689R, NGB001690R, NGB001691R, NGB001692R, NGB001693R, NGB001694R, NGB001695R, NGB001696R, NGB001697R, NGB001698R, NGB001703R, NGB001704R, NGB001706R, NGB001708R, NGB001712R, NGB001713R, NGB001713R, NGB001714R, NGB001715R, NGB001718R, NGB001719R, NGB001720R, NGB001721R, NGB001722R, NGB001723R, NGB001724R, NGB001725R, NGB001727R, NGB001728R, NGB001729R, NGB001730R, NGB001731R, NGB001732R, NGB001733R, NGB001734R, NGB001736R, NGB001737R, NGB001738R, NGB001741R, NGB001742R, NGB001743R, NGB001744R, NGB001745R, NGB001746R, NGB001747R, NGB001748R, NGB001750R, NGB001751R, NGB001752R, NGB001753R, NGB001754R, NGB001755R, NGB001756R, NGB001757R, NGB001758R, NGB001759R, NGB001760R, NGB001761R, NGB001763R, NGB001763R, NGB001764R, NGB001766R, NGB001767R, NGB001771R, NGB001772R, NGB001774R, NGB001775R, NGB001776R, NGB001777R, NGB001781R, NGB001783R, NGB001784R, NGB001786R, NGB001787R, NGB001790R, NGB001792R, NGB001793R, NGB001796R, NGB001799R, NGB001800R, NGB001801R, NGB001802R, NGB001804R, NGB001805R, NGB001811R, NGB001815R, NGB001822R, NGB001826R, NGB001829R, NGB001831R, NGB001833R, NGB001834R, NGB001835R, NGB001836R, NGB001837R, NGB001838R, NGB001839R, NGB001840R, NGB001843R, NGB001844R, NGB001845R, NGB001849R, NGB001851R, NGB001851R, NGB001893R, NGB001902R, NGB001912R, NGB001921R, NGB001921R, NGB001942R, NGB001943R, NGB001944R, NGB001945R, NGB001946R, NGB001948R, NGB001950R, NGB001962R, NGB001963R, NGB001976R, NGB001992R, NGB002020R, NGB002021R, NGB002022R, NGB002024R, NGB002026R, NGB002027R, NGB002031R, NGB002033R, NGB002036R, NGB002041R, NGB002205R, NGB002207R, NGB002208R, NGB002209R, NGB002210R, NGB002211R, NGB002212R, NGB002213R, NGB002214R, NGB002216R, NGB002217R, NGB002218R, NGB002220R, NGB002221R, NGB002222R, NGB002223R, NGB002224R, NGB002225R, NGB002226R, NGB002227R, NGB002228R, NGB002228R, NGB002253R, NGB002254R, NGB002255R, NGB002257R, NGB002258R, NGB002259R, NGB002260R, NGB002261R, NGB002262R, NGB002263R, NGB002264R, NGB002265R, NGB002266R, NGB002267R, NGB002268R, NGB002269R, NGB002270R, NGB002271R, NGB002272R, NGB002273R, NGB002274R, NGB002275R, NGB002277R, NGB002283R, NGB002287R, NGB002292R, NGB002292R, NGB002294R, NGB002296R, NGB002300R, NGB002301R, NGB002301R, NGB002303R, NGB002305R, NGB002306R, NGB002308R, NGB002309R, NGB002310R, NGB002311R, NGB002312R, NGB002312R, NGB002315R, NGB002316R, NGB002317R, NGB002319R, NGB002321R, NGB002322R, NGB002324R, NGB002325R, NGB002327R, NGB002329R, NGB002332R, NGB002333R, NGB002334R, NGB002335R, NGB002336R, NGB002337R, NGB002338R, NGB002339R, NGB002340R, NGB002342R, NGB002343R, NGB002346R, NGB002347R, NGB002348R, NGB002349R, NGB002350R, NGB002351R, NGB002352R, NGB002353R, NGB002354R, NGB002355R, NGB002356R, NGB002362R, NGB002363R, NGB002366R, NGB002367R, NGB002368R, NGB002369R, NGB002370R, NGB002371R, NGB002372R, NGB002373R, NGB002374R, NGB002375R, NGB002376R, NGB002377R, NGB002378R, NGB002379R, NGB002380R, NGB002381R, NGB002382R, NGB002383R, NGB002384R, NGB002385R, NGB002386R, NGB002387R, NGB002388R, NGB002389R, NGB002390R, NGB002391R, NGB002392R, NGB002399R, NGB002402R, NGB002409R, NGB002413R, NGB002415R, NGB002419R, NGB002420R, NGB002575R, NGB002614R, NGB002615R, NGB002615R, NGB002626R, NGB002633R, NGB002634R, NGB002634R, NGB003181R, NGB006211R, NGB006302R, NGC000001R, NGC000002R, NGC000011R, NGC000018R, NGC000019R, NGC000026R, NGC000027R, NGC000027R, NGC000027R, NGC000027R, NGC000027R, NGC000027R, NGC000034R, NGC000034R, NGC000035R, NGC000057R, NGC000058R, NGC000058R, NGC000060R, NGC000060R, NGC000066R, NGC000067R, NGC000067R, NGC000079R, NGC000082R, NGC000087R, NGC000089R, NGC000098R, NGC000100R, NGC000100R, NGC000101R, NGC000105R, NGC000110R, NGC000110R, NGC000113R, NGC000116R, NGC000117R, NGC000122R, NGC000126R, NGC000126R, NGC000127R, NGC000129R, NGC000143R, NGC000144R, NGC000146R, NGC000165R, NGC000167R, NGC000168R, NGC000180R, NGD000009R, NGD000018R, NGD000019R, NGD000020R, NGD000021R, NGD000022R, NGD000027R, NGD000031R, NGD000033R, NGD000034R, NGD000035R, NGD000037R, NGD000042R, NGD000043R, NGD000044R, NGD000046R, NGD000047R, NGD000048R, NGD000049R, NGD000051R, NGD000052R, NGD000054R, NGD000055R, NGD000057R, NGD000057R, NGD000058R, NGD000062R, NGD000063R, NGD000064R, NGD000065R, NGD000066R, NGD000067R, NGD000068R, NGD000069R, NGD000071R, NGD000074R, NGD000075R, NGD000076R, NGD000077R, NGD000078R, NGD000079R, NGD000081R, NGD000082R, NGD000084R, NGD000086R, NGD000087R, NGD000089R, NGD000090R, NGD000091R, NGD000092R, NGD000092R, NGD000096R, NGD000098R, NGD000098R, NGD000102R, NGD000103R, NGD000105R, NGD000106R, NGD000107R, NGD000108R, NGD000109R, NGD000112R, NGD000114R, NGD000116R, NGD000119R, NGD000122R, NGD000123R, NGD000124R, NGD000125R, NGD000129R, NGD000135R, NGD000135R, NGD000144R, NGD000145R, NGD000146R, NGD000148R, NGD000149R, NGD000150R, NGD000151R, NGD000152R, NGD000153R, NGD000154R, NGD000155R, NGD000156R, NGD000157R, NGD000158R, NGD000159R, NGD000160R, NGD000168R, NGD000169R, NGD000177R, NGD000184R, NGD000185R, NGD000187R, NGD000189R, NGD000191R, NGD000201R, NGD000204R, NGD000206R, NGD000208R, NGD000210R, NGD000211R, NGD000223R, NGD000233R, NGD000235R, NGD000256R, NGD000256R, NGD000270R, NGD000274R, NGD000280R, NGD000321R, NGD000359R, NGD000424R, NGE000032R, NGE000048R, NGE000049R, NGE000050R, NGE000051R, NGE000052R, NGE000053R, NGE000054R, NGE000055R, NGE000058R, NGE000060R, NGE000061R, NGE000062R, NGE000063R, NGE000068R, NGE000072R, NGE000072R, NGE000073R, NGE000075R, NGE000076R, NGE000077R, NGE000078R, NGE000079R, NGE000080R, NGE000083R, NGE000084R, NGE000085R, NGE000086R, NGE000087R, NGE000088R, NGE000090R, NGE000092R, NGE000098R, NGE000099R, NGE000099R, NGE000101R, NGE000103R, NGE000106R, NGE000107R, NGE000116R, NGE000124R, NGE000133R, NGE000139R, NGE000139R, NGE000142R, NGE000145R, NGE000157R, NGE000158R, NGE000159R, NGE000164R, NGE000166R, NGE000169R, NGE000170R, NGE000170R, NGE000170R, NGE000170R, NGE000170R, NGE000170R, NGE000181R, NGE000181R, NGE000181R, NGE000181R, NGE000181R, NGE000181R, NGE000186R, NGE000190R, NGE000192R, NGE000196R, NGE000198R, NGE000203R, NGE000203R, NGE000203R, NGE000203R, NGE000203R, NGE000203R, NGE000205R, NGE000208R, NGE000209R, NGE000210R, NGE000211R, NGE000213R, NGE000219R, NGE000221R, NGE000225R, NGE000226R, NGE000230R, NGE000233R, NGE000233R, NGE000246R, NGE000250R, NGE000251R, NGE000252R, NGE000252R, NGE000259R, NGE000259R, NGE000263R, NGE000267R, NGE000269R, NGE000272R, NGE000273R, NGE000276R, NGE000279R, NGE000279R, NGE000282R, NGE000283R, NGE000284R, NGE000286R, NGE000289R, NGE000289R, NGE000296R, NGE000297R, NGE000298R, NGE000299R, NGE000303R, NGE000304R, NGE000306R, NGE000307R, NGE000308R, NGE000311R, NGE000312R, NGE000313R, NGE000314R, NGE000316R, NGE000317R, NGE000319R, NGE000320R, NGE000321R, NGE000322R, NGE000324R, NGE000326R, NGE000329R, NGE000331R, NGE000332R, NGE000333R, NGE000334R, NGE000336R, NGE000338R, NGE000345R, NGE000346R, NGE000346R, NGE000348R, NGE000351R, NGE000352R, NGE000355R, NGE000358R, NGE000359R, NGE000363R, NGE000364R, NGE000365R, NGE000369R, NGE000369R, NGE000372R, NGE000372R, NGE000376R, NGE000380R, NGE000384R, NGE000390R, NGE000398R, NGE000404R, NGE000406R, NGE000408R, NGE000409R, NGE000410R, NGE000414R, NGE000418R, NGE000427R, NGE000436R, NGE000437R, NGE000441R, NGE000444R, NGE000445R, NGE000447R, NGE000451R, NGE000454R, NGE000456R, NGE000457R, NGE000464R, NGE000467R, NGE000470R, NGE000471R, NGE000472R, NGE000474R, NGE000475R, NGE000476R, NGE000477R, NGE000478R, NGE000479R, NGE000481R, NGE000483R, NGE000484R, NGE000485R, NGE000490R, NGE000492R, NGE000495R, NGE000496R, NGE000497R, NGE000497R, NGE000499R, NGE000499R, NGE000501R, NGE000503R, NGE000505R, NGE000506R, NGE000507R, NGE000511R, NGE000514R, NGE000517R, NGE000518R, NGE000519R, NGE000521R, NGE000523R, NGE000525R, NGE000529R, NGE000531R, NGE000534R, NGE000534R, NGE000534R, NGE000536R, NGE000538R, NGE000540R, NGE000543R, NGE000544R, NGE000555R, NGE000557R, NGE000558R, NGE000560R, NGE000560R, NGE000563R, NGE000565R, NGE000569R, NGE000570R, NGE000572R, NGE000576R, NGE000577R, NGE000587R, NGE000588R, NGE000589R, NGE000590R, NGE000592R, NGE000594R, NGE000598R, NGE000600R, NGE000601R, NGE000606R, NGE000607R, NGE000616R, NGE000618R, NGE000620R, NGE000621R, NGE000622R, NGE000622R, NGE000628R, NGE000629R, NGE000630R, NGE000633R, NGE000633R, NGE000636R, NGE000638R, NGE000640R, NGE000642R, NGE000644R, NGE000648R, NGE000650R, NGE000651R, NGE000653R, NGE000654R, NGE000655R, NGE000659R, NGE000663R, NGE000667R, NGE000667R, NGE000673R, NGE000675R, NGE000680R, NGE000684R, NGE000685R, NGE000689R, NGE000690R, NGE000691R, NGE000691R, NGE000692R, NGE000693R, NGE000694R, NGE000697R, NGE000698R, NGE000700R, NGE000701R, NGE000702R, NGE000703R, NGE000704R, NGE000705R, NGE000706R, NGE000707R, NGE000712R, NGE000716R, NGE000717R, NGE000719R, NGE000720R, NGE000720R, NGE000721R, NGE000721R, NGE000722R, NGE000725R, NGE000728R, NGE000728R, NGE000731R, NGE000734R, NGE000738R, NGE000739R, NGE000744R, NGE000747R, NGE000748R, NGE000750R, NGE000756R, NGE000756R, NGE000763R, NGE000763R, NGE000765R, NGE000765R, NGE000769R, NGE000769R, NGE000771R, NGE000779R, NGE000783R, NGE000789R, NGE000793R, NGE000793R, NGE000797R, NGE000798R, NGE000799R, NGE000799R, NGE000800R, NGE000800R, NGE000804R, NGE000804R, NGE000805R, NGE000814R, NGE000824R, NGE000825R, NGE000826R, NGE000826R, NGE000827R, NGE000829R, NGE000832R, NGE000832R, NGE000833R, NGE000834R, NGE000835R, NGE000855R, NGE000858R, NGE000858R, NGE000862R, NGE000874R, NGE000878R, NGE000878R, NGE000887R, NGE000888R, NGE000889R, NGE000890R, NGE000891R, NGE000892R, NGE000894R, NGE000896R, NGE000897R, NGE000898R, NGE000904R, NGE000905R, NGE000907R, NGE000907R, NGE000914R, NGE000914R, NGE000917R, NGE000940R, NGE000941R, NGF000021R, NGF000044R, NGF000044R, NGF000045R, NGF000047R, NGF000049R, NGF000050R, NGF000052R, NGF000055R, NGF000059R, NGF000060R, NGF000061R, NGF000062R, NGF000062R, NGF000063R, NGF000066R, NGF000067R, NGF000069R, NGF000070R, NGF000071R, NGF000073R, NGF000074R, NGF000075R, NGF000076R, NGF000082R, NGF000084R, NGF000085R, NGF000086R, NGF000088R, NGF000090R, NGF000091R, NGF000093R, NGF000094R, NGF000094R, NGF000094R, NGF000094R, NGF000094R, NGF000094R, NGF000096R, NGF000097R, NGF000101R, NGF000102R, NGF000103R, NGF000107R, NGF000109R, NGF000110R, NGF000111R, NGF000121R, NGF000121R, NGF000123R, NGF000124R, NGF000126R, NGF000130R, NGF000131R, NGF000132R, NGF000134R, NGF000135R, NGF000136R, NGF000139R, NGF000140R, NGF000143R, NGF000144R, NGF000145R, NGF000147R, NGF000148R, NGF000149R, NGF000150R, NGF000151R, NGF000154R, NGF000155R, NGF000156R, NGF000158R, NGF000159R, NGF000162R, NGF000163R, NGF000164R, NGF000167R, NGF000168R, NGF000169R, NGF000172R, NGF000175R, NGF000177R, NGF000180R, NGF000182R, NGF000183R, NGF000187R, NGF000188R, NGF000191R, NGF000192R, NGF000194R, NGF000195R, NGF000195R, NGF000195R, NGF000195R, NGF000195R, NGF000195R, NGF000196R, NGF000201R, NGF000204R, NGF000207R, NGF000208R, NGF000210R, NGF000213R, NGF000214R, NGF000215R, NGF000217R, NGF000218R, NGF000221R, NGF000225R, NGF000225R, NGF000226R, NGF000227R, NGF000227R, NGF000228R, NGF000230R, NGF000231R, NGF000233R, NGF000234R, NGF000234R, NGF000236R, NGF000237R, NGF000238R, NGF000244R, NGF000245R, NGF000246R, NGF000247R, NGF000248R, NGF000249R, NGF000251R, NGF000252R, NGF000255R, NGF000260R, NGF000261R, NGF000262R, NGF000263R, NGF000268R, NGF000271R, NGF000272R, NGF000274R, NGF000275R, NGF000277R, NGF000280R, NGF000282R, NGF000284R, NGF000286R, NGF000287R, NGF000288R, NGF000290R, NGF000293R, NGF000294R, NGF000296R, NGF000299R, NGF000300R, NGF000302R, NGF000302R, NGF000303R, NGF000306R, NGF000307R, NGF000308R, NGF000309R, NGF000310R, NGF000310R, NGF000311R, NGF000311R, NGF000313R, NGF000314R, NGF000315R, NGF000316R, NGF000317R, NGF000323R, NGF000324R, NGF000326R, NGF000327R, NGF000328R, NGF000333R, NGF000339R, NGF000341R, NGF000342R, NGF000348R, NGF000350R, NGF000351R, NGF000352R, NGF000354R, NGF000364R, NGF000365R, NGF000369R, NGF000370R, NGF000370R, NGF000371R, NGF000372R, NGF000373R, NGF000374R, NGF000375R, NGF000376R, NGF000377R, NGF000378R, NGF000381R, NGF000382R, NGF000383R, NGF000385R, NGF000386R, NGF000388R, NGF000390R, NGF000391R, NGF000392R, NGF000392R, NGF000393R, NGF000395R, NGF000397R, NGF000399R, NGF000400R, NGF000401R, NGF000408R, NGF000413R, NGF000413R, NGF000414R, NGF000416R, NGF000418R, NGF000418R, NGF000420R, NGF000421R, NGF000422R, NGF000434R, NGF000434R, NGF000436R, NGF000438R, NGF000439R, NGF000440R, NGF000442R, NGF000443R, NGF000445R, NGF000446R, NGF000447R, NGF000448R, NGF000450R, NGF000451R, NGF000452R, NGF000453R, NGF000455R, NGF000457R, NGF000459R, NGF000460R, NGF000461R, NGF000462R, NGF000463R, NGF000464R, NGF000465R, NGF000467R, NGF000468R, NGF000469R, NGF000470R, NGF000472R, NGF000473R, NGF000476R, NGF000478R, NGF000481R, NGF000482R, NGF000485R, NGF000486R, NGF000488R, NGF000489R, NGF000491R, NGF000493R, NGF000496R, NGF000497R, NGF000498R, NGF000499R, NGF000500R, NGF000501R, NGF000502R, NGF000503R, NGF000504R, NGF000505R, NGF000506R, NGF000507R, NGF000508R, NGF000508R, NGF000509R, NGF000510R, NGF000511R, NGF000514R, NGF000516R, NGF000517R, NGF000519R, NGF000520R, NGF000521R, NGF000524R, NGF000524R, NGF000526R, NGF000526R, NGF000528R, NGF000531R, NGF000533R, NGF000534R, NGF000535R, NGF000536R, NGF000537R, NGF000540R, NGF000541R, NGF000542R, NGF000547R, NGF000549R, NGF000550R, NGF000551R, NGF000558R, NGF000559R, NGF000562R, NGF000563R, NGF000565R, NGF000566R, NGF000568R, NGF000569R, NGF000570R, NGF000571R, NGF000571R, NGF000572R, NGF000573R, NGF000574R, NGF000577R, NGF000579R, NGF000580R, NGF000582R, NGF000583R, NGF000584R, NGF000590R, NGF000592R, NGF000595R, NGF000596R, NGF000597R, NGF000598R, NGF000603R, NGF000607R, NGF000610R, NGF000611R, NGF000612R, NGF000614R, NGF000615R, NGF000616R, NGF000617R, NGF000623R, NGF000629R, NGF000630R, NGF000633R, NGF000634R, NGF000635R, NGF000637R, NGF000639R, NGF000641R, NGF000644R, NGF000645R, NGF000649R, NGF000657R, NGF000664R, NGF000672R, NGF000682R, NGF000688R, NGF000704R, NGF000708R, NGF000709R, NGF000725R, NGF000725R, NGF000747R, NGF000758R, NGF000765R, NGF000765R, NGF000784R, NGF000787R, NGF000789R, NGF000792R, NGF000795R, NGF000802R, NGF000808R, NGF000808R, NGF000814R, NGF000814R, NGF000825R, NGF000825R, NGF000825R, NGF000825R, NGF000825R, NGF000825R, NGF000828R, NGF000828R, NGF000829R, NGF000843R, NGF000843R, NGF000858R, NGF000858R, NGF000875R, NGF000883R, NGF000890R, NGF000893R, NGF000894R, NGF000900R, NGF000907R, NGF000907R, NGF000918R, NGF000923R, NGF000929R, NGF000930R, NGF000932R, NGF000942R, NGF000942R, NGF000945R, NGF000958R, NGF000961R, NGF000962R, NGF000962R, NGF000972R, NGF000981R, NGF000981R, NGF000990R, NGF000990R, NGF000990R, NGF000990R, NGF000990R, NGF000990R, NGF001001R, NGF001003R, NGF001011R, NGF001015R, NGF001016R, NGF001017R, NGF001018R, NGF001020R, NGF001022R, NGF001023R, NGF001024R, NGF001025R, NGF001026R, NGF001026R, NGF001027R, NGF001028R, NGF001032R, NGF001033R, NGF001036R, NGF001036R, NGF001039R, NGF001047R, NGF001076R, NGF001078R, NGF001090R, NGF001096R, NGF001096R, NGF001099R, NGF001101R, NGF001105R, NGF001109R, NGF001124R, NGF001131R, NGF001141R, NGF001142R, NGF001149R, NGF001162R, NGF001173R, NGF001185R, NGF001185R, NGF001187R, NGF001187R, NGF001191R, NGF001191R, NGF001199R, NGF001199R, NGF001200R, NGF001200R, NGF001204R, NGF001204R, NGF001204R, NGF001204R, NGF001204R, NGF001204R, NGF001210R, NGF001229R, NGF001235R, NGF001239R, NGF001242R, NGF001261R, NGF001276R, NGF001276R, NGF001279R, NGF001287R, NGF001294R, NGF001302R, NGF001310R, NGF001314R, NGF001318R, NGF001321R, NGF001322R, NGF001324R, NGF001325R, NGF001328R, NGF001332R, NGF001338R, NGF001342R, NGF001347R, NGF001349R, NGF001352R, NGF001353R, NGF001353R, NGF001362R, NGF001362R, NGF001367R, NGF001369R, NGF001372R, NGF001372R, NGF001374R, NGF001374R, NGF001385R, NGF001388R, NGF001394R, NGF001398R, NGF001398R, NGF001407R, NGF001413R, NGF001413R, NGF001415R, NGF001417R, NGF001422R, NGF001425R, NGF001459R, NGF001459R, NGF001464R, NGF001477R, NGF001480R, NGF001489R, NGF001489R, NGF001500R, NGF001502R, NGF001504R, NGF001508R, NGF001515R, NGF001524R, NGF001527R, NGF001529R, NGF001532R, NGF001539R, NGF001539R, NGF001540R, NGF001542R, NGF001544R, NGF001548R, NGF001549R, NGF001552R, NGF001553R, NGF001556R, NGF001557R, NGF001559R, NGF001595R, NGF001595R, NGF001595R, NGF001596R, NGF001606R, NGF001608R, NGF001608R, NGF001608R, NGF001608R, NGF001608R, NGF001608R, NGF001611R, NGF001612R, NGF001613R, NGF001614R, NGF001617R, NGF001617R, NGF001617R, NGF001617R, NGF001617R, NGF001617R, NGF001636R, NGF001641R, NGF001646R, NGF001650R, NGF001659R, NGF001659R, NGF001666R, NGF001678R, NGF001678R, NGF001680R, NGF001681R, NGF001684R, NGF001688R, NGF001691R, NGF001695R, NGF001696R, NGF001696R, NGF001715R, NGF001715R, NGF001725R, NGF001740R, NGF001741R, NGF001755R, NGF001761R, NGF001766R, NGF001769R, NGF001770R, NGF001773R, NGF001789R, NGF001797R, NGF001807R, NGF001813R, NGF001821R, NGF001829R, NGF001829R, NGF001855R, NGF001862R, NGF001869R, NGF001869R, NGF001870R, NGF001870R, NGF001892R, NGF001898R, NGF001904R, NGF001905R, NGF001909R, NGF001910R, NGF001918R, NGF001918R, NGF001927R, NGF001934R, NGF001934R, NGF001945R, NGF001958R, NGF001958R, NGF001959R, NGF001965R, NGF001966R, NGF001966R, NGF001967R, NGF001973R, NGF001975R, NGF001977R, NGF001988R, NGF001990R, NGF001990R, NGF002009R, NGF002011R, NGF002024R, NGF002025R, NGF002032R, NGF002039R, NGF002044R, NGF002044R, NGF002048R, NGF002049R, NGF002051R, NGF002063R, NGF002063R, NGF002064R, NGF002070R, NGF002070R, NGF002076R, NGF002080R, NGF002080R, NGF002082R, NGF002092R, NGF002092R, NGF002099R, NGF002099R, NGF002108R, NGF002108R, NGF002115R, NGF002117R, NGF002118R, NGF002124R, NGF002130R, NGF002131R, NGF002147R, NGF002150R, NGF002154R, NGF002170R, NGF002170R, NGF002171R, NGF002178R, NGF002182R, NGF002183R, NGF002185R, NGF002191R, NGF002191R, NGF002192R, NGF002196R, NGF002214R, NGF002217R, NGF002230R, NGF002235R, NGF002238R, NGF002246R, NGF002252R, NGF002276R, NGF002278R, NGF002280R, NGF002283R, NGF002285R, NGF002291R, NGF002295R, NGF002311R, NGF002315R, NGF002315R, NGF002321R, NGF002337R, NGF002337R, NGF002339R, NGF002348R, NGF002349R, NGF002356R, NGF002356R, NGF002371R, NGF002386R, NGF002387R, NGF002388R, NGF002389R, NGF002393R, NGF002394R, NGF002397R, NGF002398R, NGF002398R, NGF002401R, NGF002402R, NGF002403R, NGF002404R, NGF002410R, NGF002412R, NGF002413R, NGF002414R, NGF002420R, NGF002421R, NGF002426R, NGF002428R, NGF002434R, NGF002436R, NGF002439R, NGF002439R, NGF002444R, NGF002444R, NGF002446R, NGF002449R, NGF002463R, NGF002467R, NGF002475R, NGF002476R, NGF002480R, NGF002493R, NGF002496R, NGF002502R, NGF002505R, NGF002506R, NGF002507R, NGF002519R, NGF002534R, NGF002537R, NGF002540R, NGF002543R, NGF002564R, NGF002566R, NGF002566R, NGF002569R, NGF002572R, NGF002581R, NGF002581R, NGF002586R, NGF002587R, NGF002590R, NGF002592R, NGF002594R, NGF002595R, NGF002603R, NGF002610R, NGF002612R, NGF002614R, NGF002621R, NGF002622R, NGF002625R, NGF002635R, NGF002636R, NGF002645R, NGF002648R, NGF002649R, NGF002651R, NGF002653R, NGF002653R, NGF002654R, NGF002656R, NGF002659R, NGF002662R, NGF002663R, NGF002666R, NGF002667R, NGF002668R, NGF002670R, NGF002671R, NGF002671R, NGF002674R, NGF002675R, NGF002679R, NGF002680R, NGF002682R, NGF002684R, NGF002685R, NGF002685R, NGF002686R, NGF002698R, NGF002703R, NGF002707R, NGF002713R, NGF002719R, NGF002724R, NGF002724R, NGF002727R, NGF002731R, NGF002732R, NGF002732R, NGF002761R, NGF002770R, NGF002771R, NGF002773R, NGF002773R, NGF002777R, NGF002780R, NGF002784R, NGF002785R, NGF002786R, NGF002788R, NGF002789R, NGF002790R, NGF002793R, NGF002794R, NGF002800R, NGF002801R, NGF002803R, NGF002805R, NGF002805R, NGF002807R, NGF002808R, NGF002810R, NGF002812R, NGF002813R, NGF002814R, NGF002816R, NGF002817R, NGF002817R, NGF002818R, NGF002822R, NGF002822R, NGF002825R, NGF002827R, NGF002828R, NGF002829R, NGF002830R, NGF002831R, NGF002833R, NGF002835R, NGF002853R, NGF002855R, NGF002873R, NGF002873R, NGF002874R, NGF002876R, NGF002876R, NGF002892R, NGF002898R, NGF002902R, NGF002903R, NGF002903R, NGF002907R, NGF002915R, NGF002921R, NGF002921R, NGF002923R, NGF002932R, NGF002936R, NGF002942R, NGF002945R, NGF002946R, NGF002952R, NGF002956R, NGF002957R, NGF002957R, NGF002959R, NGF002967R, NGF002968R, NGF002969R, NGF002971R, NGF002975R, NGF002978R, NGF002979R, NGF002983R, NGF002984R, NGF002988R, NGF002992R, NGF002993R, NGF002997R, NGF002997R, NGF002998R, NGF003001R, NGF003002R, NGF003002R, NGF003003R, NGF003003R, NGF003004R, NGF003006R, NGF003011R, NGF003013R, NGF003016R, NGF003023R, NGF003026R, NGF003028R, NGF003029R, NGF003034R, NGF003035R, NGF003036R, NGF003042R, NGF003043R, NGF003050R, NGF003050R, NGF003051R, NGF003052R, NGF003053R, NGF003054R, NGF003056R, NGF003056R, NGF003056R, NGF003056R, NGF003056R, NGF003056R, NGF003059R, NGF003060R, NGF003065R, NGF003076R, NGF003076R, NGF003085R, NGF