AUGUST 2001
WEEK ENDING AUGUST 4
PRODUCT AND CODE:
Castle
Model GCL 500 Surgical Light;
Castle
Model GCL 550 Surgical Light;
Castle
Model GCL 750 Surgical Light;
500
Series Lamp Head, Serial #GL 9911017 - GL 0003051.
REASON: Excessive force on the surgical lamp head may
cause one of the welded joints in the suspension yoke to fail.
MANUFACTURER/RECALLING FIRM: Getinge/Castle, Inc.,
North Charleston, SC
DISTRIBUTION: Nationwide and Canada, Sweden, South
Africa, Egypt, Malaysia and Mexico
QUANTITY: 182
PRODUCT AND CODE: H-TRONplusV100 Insulin
Infusion Pump
REASON: Labeling claims insulin pump is waterproof but
some pumps malfunctioned when exposed to water.
MANUFACTURER/RECALLING FIRM: Disetronic Medical
Systems, St. Paul, MN
DISTRIBUTION: Nationwide
QUANTITY: 30,000
PRODUCT AND CODE: Medtronic Membrane
Oxygenator with Integral Heat Exchangers Model Number I-4500-2A
Medtronic
Membrane Oxygenator with Integral Heat Exchangers Model Number I-3500-2A.
CODE:
The firm distributed 7 units from lot 0103002433 (Model I-4500-2A) for clinical
use, and 46 units of lot 0103002707(Model I-3500-2A) for non-clinical use.
REASON: Shorter than specified forced aeration has
resulted in higher EtO levels.
MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC.,
MINNEAPOLIS, MN 55432
DISTRIBUTION: MI, MO, NC and CA
QUANTITY: 53 units
PRODUCT AND CODE: Silhouette Five-Sided Nut
Driver (part 7010-0021-00) for the Sulzer
Spine-Tech Silhouette Spinal Fixation System. The Five-Sided Nut Driver is distributed in a case of instruments
labeled "SILHOUETTE SCREW INSTRUMENT
GENERIC
CASE COMPLETE SET:
7050-0000-00". CODE: ALL LOTS.
REASON: The socket of a tool used for locking nuts for a
spinal fixation device can slip.
MANUFACTURER: Beere Precision, Racine, WI; Metal Craft
Machine & Engineering, Inc., Elk River, MN; and Houck Machine Company,
Minneapolis, MN.
RECALL BY: SULZER SPINE-TECH , MINNEAPOLIS, MN
DISTRIBUTION: 1 to U.S. and 53 distributed to Australia,
China, Japan, South Korea and Switzerland.
QUANTITY: 304 tools (Estimated 240 in possession of company
representatives).
PRODUCT AND CODE: ZOmega IV Angiographic
Table, (angiographic x-ray system), Model: 2120637;
ZOmega
IV Angiographic Table, (angiographic x-ray system), Model: 2219154;
ZOmega
IV Angiographic Table, (angiographic x-ray system), Model: 2154474;
ZOmega
IV Angiographic Table, (angiographic x-ray system), Model: 2219155;
ZOmega
IV Angiographic Table, (angiographic x-ray system), Model: 2252036;
ZOmega
IV Angiographic Table, (angiographic x-ray system), Model: 2252037
Code
Information: Model Numbers: 2120637,
2219154, 2154474, 2219155 - All units manufactured are to be corrected. Model Numbers 2252036, 2252037 - All units
manufactured prior to May, 2001 are to be corrected.
REASON: Cable that controls table movement could break
resulting in uncontrolled motion
MANUFACTURER: GE MEDICAL SYSTEMS EUROPE, FRANCE
RECALL BY: GENERAL ELECTRIC MEDICAL, WAUKESHA, WI
DISTRIBUTION: Nationwide and Canada, Europe, Latin America
and Asia
QUANTITY: 512 nationwide and 700 worldwide
PRODUCT AND CODE: Medtronic Micro Jewel II
Implantable Cardioverter Defibrillator, Model 7223Cx
CODE:
There are about 8000 mostly non-consecutive serial numbers which are not in one
or a few ranges. The devices were made and distributed in the last month of
1996 and the first half of 1997.
REASON: Extended Charge times, which can delay the
delivery of cardioversion and defibrillation therapies, and allow the extension
of ventricular fibrillation or other tachyarrhythmia event.
MANUFACTURER/RECALLING FIRM: Medtronic, Inc.,
Minneapolis, MN 55432-3576 Medtronic Med Rel, Inc. Rd, Puerto Rico 00791
Medtronic, B.V. European Service and Technology Center, The Netherlands
RECALL BY: MEDTRONIC, INC., MINNEAPOLIS, MN
DISTRIBUTION: Nationwide and worldwide
QUANTITY: 8000 defibrillators
PRODUCT AND CODE: X-100 Suspension System
for Carl Zeiss Dental Surgical Microscope, Catalog Numbers: 000000-1080-347,
000000-1080-344, 000000-1080-324. Serial Numbers: 346526,346422,346522,346517,346505,346501,346518,349893,
351941,351972,351932,351971,346418,346518,349893,351941,351972,351932,351971,346
418,350201,346558,350308,350373,351921, and 351924
REASON: A tertiary screw in the microscope-to-stand
coupling may not secure the coupling of two components.
MANUFACTURER/RECALLING FIRM: Carl Zeiss, Inc.,
Thornwood, N.Y. 10594
DISTRIBUTION: Nationwide
QUANTITY: 19
PRODUCT AND CODE: Roche HbAlc Calibrator,
Code: Catalog No. 0755664/47110
REASON: A negative bias of up to 10% may be observed in
patient results.
MANUFACTURER/RECALLING FIRM: Roche Diagnostics Corps,
Indianapolis, IN
DISTRIBUTION: Nationwide and Canada
QUANTITY: 1320
PRODUCT AND CODE: Havel's brand 5-0 Plain
Gut Sterile Absorbable Surgical Suture, U.S.P., with CC-77 Needle or C-3
Needle. One needle with suture is packaged in a sterile pouch, 12 pouches per
carton. CODE: Lot Numbers: #MG02540 and #MG03830.
REASON: The sterile suture needles may be defective with
rust-like corrosion.
MANUFACTURER/RECALLING FIRM: SURGICAL SPECIALTIES CORP.
100 DENNIS DRIVE READING, PA
RECALL BY: HAVEL'S INC. 3726 LONSDALE STREET
CINCINNATI, OH
DISTRIBUTION: Nationwide
QUANTITY: 154 cartons
PRODUCT AND CODE: Architect Anti-HBS Reagent
Kitlist 7C18-30 This is an in vitro diagnostic Chemiluminescent Microparticle
Immunoassay (CMIA) for the quantitative determination of antibody to Hepatitis
B surface antigen (anti-HBs) in human serum and plasma used to monitor the
success of Hepatitis B vaccination and to monitor the convalescence and
recovery of Hepatitis B infected individuals.
CODE:
List 07C18-30, lot 71120M300
REASON: Microbial growth
MANUFACTURER/RECALLING FIRM: ABBOTT LABORATORIES, INC.
ABBOTT PARK, IL 60064
DISTRIBUTION: Japan
QUANTITY: 62 kits
PRODUCT AND CODE: Scanlan Diethrich-Potts
Scissors, Micro Fine Tips, Super Cut and Ultra Sharp.
CODES:
O94, P91, P92, P93, P94, Q91, Q92, Q93, Q94, R91, and R92
REASON: Scissors blades could break in high stress
situations (e.g. sterilization).
MANUFACTURER/RECALLING FIRM: SCANLAN INTL., INC. ST
PAUL, MN 55107
DISTRIBUTION: Nationwide and worldwide
QUANTITY: 1505 scissors
PRODUCT AND CODE: Focus Dailies Spherical
Contact Lenses, Lot No. 1096004
REASON: The primary label indicated Focus Dailies
Spherical, while the secondary label indicates Focus Dailies Progressive.
MANUFACTURER/RECALLING FIRM: Ciba Vision Corp., Duluth,
GA
DISTRIBUTION: AZ, FL, MA, MO, NM, NC, PA
QUANTITY: 10/15 packs were shipped
WEEK ENDING AUGUST 11
PRODUCT AND CODE: VARIOUS CUSTOM SURGICAL
PROCEDURE TRAYS-see specific listing under "codes" below. These are all Maxxim kits that contain
Clinipad Products implicated as Class I although the specific lot number
included in the kits cannot be determined until they are opened.
KIT
ITEM # TRAY
NAME CLINIPAD
ITEM #
82-6616 CRANIAL
ACCESS KIT, W/O DRUGS 3943S-B
BMH10BW ARTERIAL LINE TRAY 1291SB
BMH44MT EYE TRAY 1291SB
BX0003 BREAST BIOPSY
TRAY 1291SB
BXQ007 BREAST BIOPSY
PACK 1291SB
CH12CO SHOULDER
ARTHROSCOP. 3943SB
CHMC01CO INTERVENTIONAL PACK 3943SB
CMC06MF UNIBLOCK-UNIV. NERVE
BLOCK 1291SB
CTS01D0 RECOVERY TRAY 1241SB
CVSCO1MF CATARACT TRAY 1291SB
EAP010 LATEX
FREE-TYMPANOPLASTY 3943SB
ECM01ET ANGIOGRAPHY PACK 3943SB
ECMC01ENJ OPHTHALMIC PACK 1291SB
EYJ101 EYE PACK 3943SB
EYP017 ED JONES EYE
TRAY 3943SB
EYP071 EYE TRAY 3943SB
EYP091 MINI
OPHTHALMIC CUSTOM KIT 3943SB
GSH0301 VALVE A & B
PACK 3943SB
GSH04D1 CORONARY TRAY A
& B 3943SB
GSM065 VASECTOMY PACK 3943SB
GSP025 BONE MARROW
TRAY 0110
HCL372 ANGIOGRAPHY
PACK 3943SB
HCP001 CARDIAC CATH
PACK 3943SB
HMEM01ST CR. TERRELL CATARACT
PACK 3942SB
MUPO1PP CATARACT PACK 1291SB
1MH12M1 ANESTHESIA BUNDLE
CMS 1241SB
JPSH29FWT BALLOON INDUCTION TRAY 3943SB
MCG05AG PEDIATRIC CARDIAC
CATH 3943SB
MGH01SW OPHTHALMIC PACK 3943SB
M113MA ANGIOGRAPHY TRAY 3943SB
M146MA MYLOGRAM 3943SB
MMH17BF EYE PACK 3943SB
MMH18BF POSTERIOR VITRECTOMY 3943SB
MVH22DO LATEX FREE
TYMPANOPLASTY 3943SB
NNJEO1SONJ BASIC EYE PACK 3943SB
OBP049 VAGINAL
DELIVERY TRAY 3943SB
OLTRMC04CI CATARACT TRAY 3943SB
OPP195 PODIATRY SET
UP PACK 0110
PLP020 PLASTIC PACK 3943SB
RD3548 ELECTRO-PHYSIOLOGY
TRAY 3943SB
SCH08ECI TOTAL HIP TRAY 3943SB
SH01SP CATARACT TRAY 3943SB
SHH01CM CATARACT PACK 3943SB
SJO7SI BLEEDER SET
UP PACK 3943SB
SRH01GG CATH PACK 3943SB
SRHO1SO DR. ROBINSON’S EYE
PACK 3943SB
TH11CHI DIALYSIS KIT 0110
THMC12CI P.A.C. KIT 0110
UHCO1CM CATARACT PACK 3943SB
VAMCC01CO ANGIO ARTERIOGRAM CV15101 3943SB
VAMCC02CO BASIC CATH LAB PK CV15103 3943SB
VBH02LV OPEN HEART A/B/C 3943SB
WPAFB16WPO PODIATRY PACK PO22001 3943SB
REASON:
STERILE
SURGICAL KITS MAY CONTAIN NONSTERILE CLINIPAD PRODUCTS.
MANUFACTURER/RECALLING FIRM: MAXXIM MEDICAL, INC.,
NORTH CLEARWATER, FL
DISTRIBUTION: Nationwide and Canada
QUANTITY: Approx. 1,000,000 kits potentially with Clinipad
product.
PRODUCT AND CODE: 1/4 X 1/2 X 1/2 Clear PAY
with Luer Lock. 10 pouched/labeled
units per box.
REASON: Nonsterile product labeled non-sterile contained a
sterile catalog number and should have been sterile
MANUFACTURER/RECALLING FIRM: SURGIMEDICS, INC., THE
WOODLANDS, TX
RECALL BY: LifeStream International, Inc, The
Woodlands, TX
DISTRIBUTION: St. Louis, MO
QUANTITY: 70 units
PRODUCT AND CODE: Passport 2 Vital Signs
Monitor
Codes:
Passport
2 0998-00-0170-0001(A,F)
Passport
2 0998-00-0170-0002 (A,D,F,G,P,T)
Passport
2 0998-00-0170-0003 (A)
Passport
2 0998-00-0170-0004 (A,G)
Passport
2 0998-00-0170-0005 (A)
Passport
2 0998-00-0170-0006 (A,D,G)
Passport
2 0998-00-0170-0007 (A)
Passport
2 0998-00-0170-0008 (A)
Passport
2 0998-00-0170-0009 (A,F)
Passport
2 0998-00-0170-0010 (A,F,G)
Passport
2 0998-00-0170-0011 (A)
Passport
2 0998-00-0170-0012 (A,G,P)
Passport
2 0998-00-0170-0013 (A,D,F,T)
Passport
2 0998-00-0170-0014 (A,F,G,T)
Passport
2 0998-00-0170-0015 (A)
Passport
2 0998-00-0170-0016 (A)
Passport
2 0998-00-0170-0017 (A)
Passport
2 0998-00-0170-0021 (A)
Passport
2 0998-00-0170-0022 (A)
Passport
2 0998-00-0170-0023 (A)
Passport
2 0998-00-0170-0029 (A)
Passport
2 0998-00-0170-0031 (A)
Passport
2 0998-00-0170-0032 (A)
Passport
2 0998-00-0170-0034 (A,F,P)
Passport
2 0998-00-0170-0036 (A,P)
Passport
2 0998-00-0170-0037 (A)
Passport
2 0998-00-0170-0038 (A,F,G,T)
Passport
2 0998-00-0170-0039 (A)
Passport
2 0998-00-0170-0040 (A,P)
Passport
2 0998-00-0170-0041 (A)
Passport
2 0998-00-0170-0042 (A,F)
Passport
2 0998-00-0170-0044 (A,P)
Passport
2 0998-00-0170-0045 (A,F)
Passport
2 0998-00-0170-0046 (A,F,G,P,T)
Passport
2 0998-00-0170-0048 (A,P)
Passport
2 0998-00-0170-0050 (A)
Passport
2 0998-00-0170-0054 (A)
Passport
2 0998-00-0170-0055 (A)
Passport
2 0998-00-0170-0061 (A)
Passport
2 0998-00-0170-0062 (A)
Passport
2 0998-00-0170-0064 (A)
Passport
2 0998-00-0170-3006 (A,T)
Passport
2 0998-00-0170-3013 (A)
Passport
2 0998-00-0170-3014 (A,F,G,T)
Passport
2 0998-00-0170-3015 (A)
Passport
2 0998-00-0170-3016 (A,G)
Passport
2 0998-00-0170-3038 (A,T)
Passport
2 0998-00-0170-3040 (A,P)
Passport
2 0998-00-0170-3045 (A)
Passport
2 0998-00-0170-3046 (A,F,G,T)
Passport
2 0998-00-0170-3047 (A)
Passport
2 0998-00-0170-3048 (A,G,T)
REASON: Power supply fails when the printer/recorder is
activated.
MANUFACTURER/RECALLING FIRM: Datascope Corporation,
Mahwah, NJ
DISTRIBUTION: Nationwide and Austria, Belgium, Brazil,
Chile, China, Czech Republic, Egypt, France, Germany, Greece, Guatemala, Holland,
Hungary, India, Israel, Italy, Jordan, Kuwait, Mexico, Peru, Philippines, South
Africa, Spain, Syria, Thailand, Tunisia, Turkey, United Kingdom, Venezuela,
Vietnam, Zambia.
QUANTITY: 1520
PRODUCT AND CODE: Dura II Concealable Penile
Prosthesis (in sterile packaging) with 1 Pair of 10 mm Bodies, Part Number
9310, Lot/Serial Number: 007695,
Catalog Number: 9310, Expiration:
2005-10, (stands for October 2005)
REASON: 12 mm hex wrenches put in 10 mm Dura II penile
prosthesis kits
MANUFACTURER/RECALLING FIRM: TIMM MEDICAL TECHNOLOGIES,
INC., PRAIRIE, MN
DISTRIBUTION: MT, TX, PA
QUANTITY: 4 devices
PRODUCT AND CODE: ACE 2.0 PTCA Dilatation
Catheters (2.0 mm diameter balloon size), Model Number H74902071011;
Graft
ACE 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number
H74903647201; ACE 1 cm TIP 2.0 PTCA Dilatation Catheters (2.0 mm diameter
balloon size), Model Number H74903628201
CODE:
Lot numbers 3367926 and above
REASON: Slow or no balloon deflation was noticed during final
functional testing of some of the catheters.
MANUFACTURER/RECALLING FIRM: BOSTON SCIENTIFIC SCIMED,
INC. MAPLE GROVE, MN
DISTRIBUTION: Nationwide
QUANTITY: 1284 Catheters
PRODUCT AND CODE: Ventak Prism Automatic
Implantable Cardioverter Defibrillators Serial Numbers:
Ventak
Prizm VR Model 1850: 103440-103442, 103447-103470, 103472-103473, 103475,
103479-103515, 103517-103847, 103849-103880, 103882-104235, 104237-104883,
104885-104886, 104888, 104891-105008, 105010-105949, 105951-106009, 106012-109299,
109301-109303, 109305-109845
Ventak
Prizm DR Model 1851: 307946, 307972, 307976, 307988, 307995-308002,
308006-308007, 308009, 308011, 308016, 308019-308020, 308026-308028,
308030-308047, 308054, 308069-308075, 308077-308115, 308118-308146, 308148-308155,
308158-308269, 308271-308285, 308288-308309, 308311-308320, 308322-308326,
308328-308388, 308390-308406, 388408-308431, 308433-308434, 308436-308437,
308439-308665, 308667-308699, 308701-308713, 308715-308747, 308749-308790,
308792-308825, 308827-388970, 308972-308989, 308991, 308993-309294,
309296-309509, 309511-309842, 309844-310083, 310085-310095, 310098-310101,
310104-310105, 310108-310111, 310128-310175, 310177-310222, 310224-310225,
310227-310248, 310251-310307, 310309-310329, 310335-310337, 310341-310387,
310389-310409, 310411-310943, 310945-311423, 311425-312590, 312592-312815,
312817-313201, 313203-314612
Ventak
Prizm VR HE Model 1852: 100000-100507
Ventak
Prizm DR HE Model 1853: 300005-300011, 300013-300014, 300017, 300019-300020,
300022, 300031-300033, 300035, 300037-300038, 300045-300063, 300065-300066,
300068-300150, 300152, 300154-300280, 300282-300286, 300288-300317.
300319-300324, 300326-301611
Ventak
Prizm VR HE Model 1857: 500000-500123
Ventak
Prizm DR HE Model 1858: 600000-600129
REASON: Some of the defibrillators have automatically
switched to an integrated Safety Mode because of a rare interaction between the
device and a specific memory component.
MANUFACTURER/RECALLING FIRM: GUIDANT CORPORATION, CARDIAC PACEMAKERS, ST. PAUL, MN
DISTRIBUTION: Nationwide and worldwide
QUANTITY: 13,833 defibrillators
PRODUCT AND CODE: Seal-Away Coronary Sinus
Introducer Kit, Reorder Numbers 407508 & 407510 Lot number and expiration
date:
Reorder
Number 407508:
LOT
NUMBER EXPIRATION DATE
00BG78 5/2003
00CB68 7/2003
00CC67 7/2003
00CP20 9/2003
00CZ26 10/2003
99BY99 9/2002
99CP40 11/2002
99CP41 12/2002
99CP42 12/2002
Reorder
Number 407510:
LOT
NUMBER EXPIRATION DATE
01BB96 3/2004
00AY18
4/2003
00CD87 8/2003
00CP77 9/2003
99CU58 12/2002
REASON: It is possible for the Seal-Away CS sheath to
split upon insertion.
MANUFACTURER/RECALLING FIRM: ST. JUDE MEDICAL, INC.,
DAIG DIVISION, MINNETONKA, MN
DISTRIBUTION: Nationwide; United Kingdom and Ireland
QUANTITY: 2303 units (1889 units of product 407508 and 414
units of product 407510
PRODUCT AND CODE: Medtronic GEM Implantable
Cardioverter Defibrillators, Model 7227, with Interchangeable Connector, Model
5227
REASON: Even though the devices will continue to provide
therapy, the physician is led to believe that a lead failure has occurred. As a
result, lead replacement would probably be chosen in some cases when it is
unnecessary.
MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC.,
MINNEAPOLIS, MN
DISTRIBUTION: Nationwide and worldwide
QUANTITY: 1352 devices
PRODUCT AND CODE: Silhouette Spinal Fixation
System Torque-Limiting T-Handle Driver, Catalog Number: 7010-0019-00. The Torque-Limiting T-Handle Drivers were
each distributed in a case of instruments labeled "SILHOUETTE SCREW
INSTRUMENT GENERIC CASE COMPLETE SET:
7050-0000-00".
CODE:
All lots
REASON: The calibration of the device can be affected if the
adjustment screws are altered.
MANUFACTURER/RECALLING FIRM: BEEVE PRECISION, RACINE,
WI
DISTRIBUTION: About 300 of the instrument kits are in
distribution in the United States (owned by the firms sales reps.) One
instrument kit has been sold to a hospital in LaCrosse, WI. There are
distributors of the instrument kits in Australia, China, South Korea and
Switzerland. 51 of the kits were sold to consignees in these countries.
QUANTITY: 371 devices
PRODUCT AND CODE: Myotherm Cardioplegia Delivery
System, XP 4:1 (catalog number 61399404996) and XP 4:1B (catalog number
61399405331). The XP 4:1B differs from
the XP 4:1 by having a bridge connection which the XP 4:1 does not
have.MYOtherm XP 4:1 (catalog number 61399404996): lot number 0006013298
MYOtherm XP 4:1B (catalog number 61399405331): lot number 0006014173
REASON: Some of the devices are mislabeled as to whether
they have a bridge connection.
MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC.,
MINNEAPOLIS, MN
RECALL BY: MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS,
MN
DISTRIBUTION: Nationwide
QUANTITY: 290 Cardioplegia Delivery Systems
WEEK ENDING AUGUST 25
PRODUCT AND CODE: VARIOUS CUSTOM SURGICAL
PROCEDURE TRAYS-see specific listing under "codes" below. These are all Maxxim kits that contain
Clinipad Products implicated as Class I although the specific lot number
included in the kits cannot be determined until they are opened.
KIT
ITEM # TRAY NAME CLINIPAD
ITEM #
82-6616
CRANIAL
ACCESS KIT, W/O DRUGS 3943S-B
BMH10BW
ARTERIAL LINE
TRAY 1291SB
BMH44MT
EYE TRAY 1291SB
BX0003
BREAST
BIOPSY TRAY 1291SB
BXQ007
BREAST
BIOPSY PACK 1291SB
CH12CO
SHOULDER
ARTHROSCOP 3943SB
CHMC01CO
INTERVENTIONAL
PACK 3943SB
CMC06MF
UNIBLOCK-UNIV.
NERVE BLOCK 1291SB
CTS01D0
RECOVERY
TRAY 1241SB
CVSCO1MF
CATARACT TRAY 1291SB
EAP010
LATEX FREE-TYMPANOPLASTY 3943SB
ECM01ET
ANGIOGRAPHY
PACK 3943SB
ECMC01ENJ
OPHTHALMIC PACK 1291SB
EYJ101
EYE PACK
3943SB
EYP017
ED JONES
EYE TRAY 3943SB
EYP071
EYE TRAY
3943SB
EYP091
MINI
OPHTHALMIC CUSTOM KIT 3943SB
GSH0301
VALVE A
& B PACK 3943SB
GSH04D1
CORONARY
TRAY A & B 3943SB
GSM065
VASECTOMY
PACK 3943SB
GSP025
BONE
MARROW TRAY 0110
HCL372
ANGIOGRAPHY
PACK 3943SB
HCP001
CARDIAC
CATH PACK 3943SB
HMEM01ST
CR. TERRELL CATARACT
PACK 3942SB
MUPO1PP
CATARACT PACK 1291SB
1MH12M1
ANESTHESIA
BUNDLE CMS 1241SB
JPSH29FWT
BALLOON INDUCTION
TRAY 3943SB
MCG05AG
PEDIATRIC
CARDIAC CATH 3943SB
MGH01SW
OPHTHALMIC PACK
3943SB
M113MA
ANGIOGRAPHY
TRAY 3943SB
M146MA
MYLOGRAM 3943SB
MMH17BF
EYE PACK 3943SB
MMH18BF
POSTERIOR
VITRECTOMY 3943SB
MVH22DO
LATEX FREE
TYMPANOPLASTY 3943SB
NNJEO1SONJ
BASIC EYE PACK 3943SB
OBP049
VAGINAL
DELIVERY TRAY 3943SB
OLTRMC04CI
CATARACT TRAY 3943SB
OPP195
PODIATRY
SET UP PACK 0110
PLP020
PLASTIC
PACK 3943SB
RD3548
ELECTRO-PHYSIOLOGY
TRAY 3943SB
SCH08ECI
TOTAL HIP
TRAY 3943SB
SH01SP
CATARACT
TRAY 3943SB
SHH01CM
CATARACT PACK 3943SB
SJO7SI
BLEEDER
SET UP PACK 3943SB
SRH01GG
CATH PACK 3943SB
SRHO1SO
DR.
ROBINSONíS EYE PACK 3943SB
TH11CHI
DIALYSIS KIT 0110
THMC12CI
P.A.C. KIT 0110
UHCO1CM
CATARACT PACK 3943SB
VAMCC01CO
ANGIO ARTERIOGRAM
CV15101 3943SB
VAMCC02CO
BASIC CATH LAB PK
CV15103 3943SB
VBH02LV
OPEN HEART
A/B/C 3943SB
WPAFB16WPO
PODIATRY PACK PO22001 3943SB
REASON:
STERILE
SURG.KITS MAY CONTAIN NONSTERILE CLINIPAD PRODUCTS
MANUFACTURER/RECALLING FIRM: MAXXIM MEDICAL, INC., Clearwater,
FL
DISTRIBUTION: Nationwide and Canada
QUANTITY: 1,000,000
kits potentially with clinipads product.
PRODUCT AND CODE: Various Sterile Surgical
Procedure Trays (custom), Code Information: ALL SURGICAL TRAYS MANUF. AND
LABELED WITH MAXXIM MEDICAL OF CLEARWATER FL. ARE COVERED BY THIS RECALL
ACTION, ALL PRODUCT NUMBERS AND LOT NUMBERS
REASON: STERILE KITS MAY CONTAIN CLINIPAD PRODUCT-LACK OF
ASSUR OF STER.
MANUFACTURER/RECALLING FIRM: MAXXIM MEDICAL, INC. North
Clearwater, FL
DISTRIBUTION: Nationwide to Canada
QUANTITY: 1,000,000 kits
PRODUCT AND CODE: AcrySofô Brand Intraocular
Lenses
REASON: Pin holes in the sterile pouches of the
intraocular lenses.
MANUFACTURER/RECALLING FIRM: ALCON LABORATORIES, Fort
Worth, Texas
DISTRIBUTION: Nationwide & International
QUANTITY: 36,271 Lenses
PRODUCT AND CODE: Sonosite 180 - portable,
software controlled ultrasound system intended for use with a variety of
transducers to perform a variety of scans and measurements/calculations for the
abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code:
Sonosite units with the following software versions: 01.xx.003.00 to
01.xx.003.067 and 01.xx.002.yyy and 01.xx.001.yyyxx is 40, 60, or 80; and yyy
is 000 through 999
REASON: POTENTIAL FOR MISCALCULATION OF ESTIMATED DELIVERY
DATE MANUFACTURER/RECALLING FIRM:
SONOSITE,
INC., Bothell, WA
DISTRIBUTION: Nationwide and worldwide. Military
distribution: Bremerton Naval Hospital, Bremerton, WA.
QUANTITY: 1,026 units
PRODUCT AND CODE: H-TRONplus V100 Insulin
Infusion Pump
REASON: Claim of waterproofing was not cleared
MANUFACTURER/RECALLING FIRM: Disetronic Medical
Systems, St. Paul, MN
DISTRIBUTION: Nationwide
QUANTITY: 30,000 patients using the pump nationwide.
PRODUCT AND CODE: Model PC-1 A one channel,
general purpose, infusion pump, 220V CE Marked, International only (Software
version 8.12 and 8.13)
REASON: Motor stall
MANUFACTURER/RECALLING FIRM: ALARIS MEDICAL SYSTEMS,
INC., San Diego, CA
DISTRIBUTION: International and U.S. Defense Department
under contracts V797P-4091A and SP0200-98-D-8002.
QUANTITY: 5820
PRODUCT AND CODE: FlexiLab Laboratory
Information System, Version 5.23
REASON: Software anomaly
MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION
SYSTEMS, INC., Tucson AZ
DISTRIBUTION: Nationwide and DENMARK.
QUANTITY: 82
PRODUCT AND CODE: Inflatable Leg compression
wraps used to maintain cardiovascular circulation of the legs of a bed-ridden
patient. All parts are packed and labeled in part "SISS Inc. Date** Lot #
** Hos Part # ** Part Description: # **
Sisters, OR ** Product has been
EO
Gas sterilized ***", Inflatable leg compression wraps DVT 30 product
- 3574
Inflatable
Leg compression wraps used to maintain cardiovascular circulation of the legs
of a bed-ridden patient. All parts are packed and
labeled
in part "SISS Inc. Date** Lot # ** Hos Part # ** Part Description: # ** Sisters, OR ** Product has been EO Gas
sterilized ***",
Inflatable
leg compression wraps DVT 40 product - 3575
REASON: PRODUCTS ERRONEOUSLY LABELED AS STERILE
MANUFACTURER/RECALLING FIRM: Surgical Instrument
Service & Savings, Inc., Sisters, OR
DISTRIBUTION: PA
QUANTITY: 15 pkgs (1 pair/pkg) of DVT 30 compression wraps;
6 pkgs (1 pair/pkg) of DVT 40 compression wraps
PRODUCT AND CODE: Intact hCG ELISA Test kit,
catalog number KIF4013
CODE:
Lots 9906001 and 9907287
REASON: Possible false negative test results
MANUFACTURER/RECALLING FIRM: ALEXON - TREND, INC.,
Ramsey MN
DISTRIBUTION: MA, MO, NJ and Ireland and Netherlands
QUANTITY: 30 kits
PRODUCT AND CODE: Alumi-hand - a sterile,
medical device used to immobilize the patient's hand during hand
surgeries. Not implanted - single use.
Code: Alumi-Hand, large, Stock #760, Lot #I-4284
REASON: Products may not be sterile - not irradiated at proper
dose.
MANUFACTURER: STRUCKMEYER CORP. Dallas, TX
RECALLED BY: INSTRUMENT SPECIALISTS, INC., BOERNE, TX
DISTRIBUTION: Nationwide and US government/military
consignees are: Naval Hospital, Portsmouth, VA
VA
Medical Center, St. Louis, Missouri
QUANTITY: 869
PRODUCT AND CODE: Various models and lot
numbers of Bausch & Lomb Intraocular Lens Models:
Model
650CUV, 6793B, 8095B, 8191B, 8491B, 8641B, 95BUV, 95UV, BV359, BVR-150S,
BVR-160M, CEN55F, EB33B, EZE-50, FL652F, FL65LF,
IO359,
MIC6, MIC6F, P328UV, P329UV, P337UV, P356UV,P359UV, P366UV, P379UV, P492UV,
P499UV, P506UV, PERLN2, PERLN2F, PSM3,
S122UV,
SIFL2,Z130.
There
are 1639 lot numbers for each model as follows:
Model Lot 650CUV 6KV104 650CUV 6KV108 650CUV
6KV109 650CUV 6KV111 650CUV 6KV112 650CUV 6KV114 650CUV
Count
6 6793B 6J1K01 6793B 6J1K02 6793B 6J1K03 6793B 6J1K04 6793B 6J1K05 6793B 6J1K06
6793B 6J1K07 6793B 6J1K08 6793B 6J1K10 6793B 6J1K11 6793B 6J1K12 6793B 6KK401
6793B 6KK403 6793B 6KK405 6793B 6KK406 6793B 6KK407 6793B
Count
16 8095B 6CXK03 8095B 6CXK10 8095B 6CXK12 8095B 6CXK14 8095B 6CXK16 8095B
6CXN02 8095B 6CXN03 8095B 6CXN07 8095B 6CXN09 8095B 6GN903 8095B 6GN904 8095B
6GN905 8095B 6GPA01 8095B 6GPA02 8095B 6GPA03 8095B 6GPA04 8095B 6GPA05 8095B
6GPA06 8095B 6GPA12 8095B
Count
19 8191B 6CJM01 8191B 6CJM03 8191B 6CJM05 8191B 6GPB01 8191B 6GPB02 8191B
6GPB03 8191B 6GPB05 8191B 6GPB06 8191B 6GPB10 8191B 6GPB12 8191B 6GPB16 8191B
Count
11 8491B 6CJU03 8491B 6CJU05 8491B 6CJU07 8491B 6CJU08 8491B 6CJU15 8491B
6CJU16 8491B 6CJU18 8491B 6CJU22 8491B 6DLL49 8491B 6DLM01 8491B 6DLM02 8491B
6DLM03 8491B 6DLM04 8491B 6DLM05 8491B 6DLM06 8491B 6DLM07 8491B 6DLM08 8491B
6DLM09 8491B 6DLM10 8491B 6DLM11 8491B 6DLM12 8491B 6DLM13 8491B 6GPC01 8491B
Count
23 8641B 6CXX01 8641B 6CXX02 8641B
Count
2 95BUV 6DK632 95BUV 6DK633 95BUV 6DK634 95BUV 6DK635 95BUV 6DK636 95BUV 6DK637
95BUV 6KBV33 95BUV 6KBV34 95BUV 6KBV35 95BUV 6KBV36 95BUV 6KBV37 95BUV 6KBV38
95BUV 6KBV39 95BUV 6KBV40 95BUV 6KBV41 95BUV 6KBV42 95BUV 6KBV43 95BUV 6KBV44
95BUV 6KBV45 95BUV 6KBV46 95BUV 6KBV47 95BUV 6KBV48 95BUV 6KBV49 95BUV 6KBV50
95BUV 6KBW01
95BUV
6KBW02 95BUV 6KBW03 95BUV 6KBW04 95BUV 6KBW05 95BUV 6KBW06 95BUV 6KBW08 95BUV
6KBW09 95BUV 6KBW32 95BUV 6KBW33 95BUV 6KBW34 95BUV 6KBW35 95BUV 6KBY02 95BUV
6KBY03 95BUV 6KBY04 95BUV 6KBY05 95BUV 6KBY06 95BUV 6KBY07 95BUV 6KBY08 95BUV
6KBY09 95BUV 6KBY10 95BUV 6KBY11 95BUV 6KBY12 95BUV 6KBY13 95BUV 6KBY14 95BUV
6KBY15 95BUV 6KBY16 95BUV 6KBY17 95BUV 6KBY18 95BUV 6KBY19 95BUV 6KBY20 95BUV
6KBY21 95BUV 6KBY22 95BUV 6KBY23 95BUV 6KBY24 95BUV 6KBY25 95BUV 6KBY26 95BUV
6KBY27 95BUV 6KBY28 95BUV 6KBY29 95BUV 6KBY30 95BUV 6KBY31 95BUV 6KBY32 95BUV
6KBY33 95BUV 6KBY34 95BUV 6KBY35 95BUV 6KBY36 95BUV 6KBY37 95BUV 6KBY38 95BUV
6KBY39 95BUV 6KBY40 95BUV 6KBY41 95BUV 6KBY42 95BUV 6KBY43 95BUV 6KBY44 95BUV
6KBY45 95BUV 6KBY46 95BUV 6KBY47 95BUV 6KBY48 95BUV 6KBY49 95BUV 6KBY50 95BUV
6KBY51 95BUV 6KBY52 95BUV 6KBY53 95BUV 6KBY54 95BUV 6KBY55 95BUV 6KBY56 95BUV
6KBY57 95BUV 6KBY58 95BUV 6KBY59 95BUV 6KBY60 95BUV
Count
95 95UV 6KYC01 95UV 6KYC02 95UV 6KYC03 95UV 6KYC04 95UV
Count
4 BV359 6D3K01 BV359 6D3K02 BV359 6D3K03 BV359 6D3K04 BV359 6D3K05 BV359 6D3K06
BV359 6D3K07 BV359 6D3K08 BV359 6D3K09 BV359 6D3K10 BV359 6D3K11 BV359 6D3K12
BV359 6D3K13 BV359 6D3K14 BV359 6D3K15 BV359 6D3K16 BV359 6D3K17 BV359 6D3K18
BV359 6D3K19 BV359 6D3K20 BV359 6D3K21 BV359 6D3K22 BV359 6D3K23 BV359 6D3K24
BV359 6D3K25 BV359 6D3K26 BV359 6D3K27 BV359 6D3K28 BV359 6D3K29 BV359 6D3K30
BV359 6D3K32 BV359 6D3K33 BV359 6D3K34 BV359 6D3K35 BV359 6D3K36 BV359 6D3K37
BV359 6D3K38 BV359 6D3K39 BV359 6D3K40 BV359 6D3K41 BV359 6D3K42 BV359 6D3K43
BV359 6D3K44 BV359 6D3K45 BV359 6D3K46 BV359 6D3K47 BV359 6D3K48 BV359 6D3K49
BV359 6D3K52 BV359 6D3K53 BV359 6D3K54 BV359 6D3K55 BV359 6D3K56 BV359 6D3K57
BV359 6D3K58 BV359 6D3K59 BV359 6D3K60 BV359 6D3K61 BV359 6D3K62 BV359 6D3K63
BV359 6D3K64 BV359 6D3K65 BV359 6D3K66 BV359 6D3K67 BV359 6D3K68 BV359 6D3K69
BV359 6D3K70 BV359 6D3K71 BV359 6D3K72 BV359 6D3K73 BV359 6D3K74 BV359 6D3K76
BV359 6D3K77 BV359 6D3K78 BV359 6D3K79 BV359 6D3K80 BV359 6D3K81 BV359 6D3K82
BV359 6D3K83 BV359 6D3K84 BV359 6D3K85 BV359 6D3K86 BV359 6D3K87 BV359 6D3K88
BV359 6D3K89 BV359 6D3K90 BV359 6KC501 BV359 6KC502 BV359 6KC503 BV359 6KC504
BV359 6KC505 BV359 6KC506 BV359 6KC507 BV359 6KC508 BV359 6KC509 BV359 6KC510
BV359 6KC511 BV359 6KC512 BV359 6KC513 BV359 6KC514 BV359 6KC515 BV359 6KC516
BV359 6KC517 BV359 6KCB01 BV359 6KCB02 BV359 6KCB03 BV359 6KCB04 BV359 6KCB05
BV359 6KCB06 BV359 6KCB07 BV359 6KCB08 BV359 6KCB09 BV359 6KCB10 BV359 6KCB11 BV359
6KCB12 BV359 6KCB13 BV359 6KCB14 BV359 6KCB15 BV359 6KCB16 BV359 6KCB17 BV359
6KCB18 BV359 6KCB19 BV359 6KCB20 BV359 6KCB21 BV359 6KCB22
BV359
6KCB23 BV359 6KCB24 BV359 6KCB25 BV359 6KCB26 BV359 6KCB27 BV359 6KCB28 BV359
6KCB29 BV359 6KCB30 BV359 6KCB31 BV359 6KCB32 BV359 6KCB33 BV359 6KCB34 BV359
6KCB35 BV359 6KCB36 BV359 6KCB37 BV359 6KCB38 BV359 6KCB39 BV359 6KCB40 BV359
6KCB41 BV359 6KCB42 BV359 6KCB43 BV359 6KCB44 BV359 6KCB45 BV359 6KCB46 BV359
6KCB47 BV359 6KCB48 BV359 6KCB49 BV359 6KCB50 BV359 6KCB51 BV359 6KCB52 BV359
6KCB53 BV359 6KCB54 BV359 6KCB55 BV359 6KCB56 BV359 6KCB57 BV359 6KCB58 BV359
6KCB59 BV359 6KCB60 BV359 6KCB61 BV359 6KCB62 BV359 6KCB63 BV359 6KCB64 BV359
6KCB65 BV359 6KCB66 BV359 6KCB67
BV359
6KCB68 BV359 6KCB69 BV359 6KCB70 BV359 6KCB71 BV359 6KCB72 BV359 6KCB73 BV359
6KCB74 BV359 6KCB75 BV359 6KCB76 BV359 6KCB77 BV359 6KCB78 BV359 6KCB79 BV359
6KCB80 BV359 6KCB81 BV359 6KCB82 BV359 6KCB83 BV359 6KCB84 BV359 6KCB85 BV359
6KCB86 BV359 6KCB87 BV359 6KCB88 BV359 6KCB89 BV359 6KCR01 BV359 6KCR02 BV359
6KCR03 BV359 6KCR04 BV359 6KCR05 BV359 6KCR06 BV359 6KCR07 BV359 6KCR08 BV359
6KCR09 BV359 6KCR10 BV359 6KCR11 BV359 6KCR12 BV359 6KCR13 BV359 6KCR14 BV359
6KCR15 BV359 6KCR16 BV359 6KCR17 BV359 6KCR18 BV359 6KCR19 BV359 6KDB01 BV359
6KDB02 BV359 6KDB03 BV359 6KDB04
BV359
6KDB05 BV359 6KDB06 BV359 6KDB07 BV359 6KDB32 BV359 6KDB33 BV359 6KDB34 BV359
6KDB35 BV359 6KDB36 BV359 6KDB37 BV359 6KDB38 BV359 6KDB39 BV359 6KDB40 BV359
6KDB41 BV359 6KDB42 BV359 6KDB43 BV359 6KDB44 BV359 6KDB45 BV359 6KDB46 BV359
6KDB47 BV359 6KDB48 BV359 6KDB49 BV359 6KDB50 BV359 6KDB51 BV359 6KDB52 BV359
6KDB53 BV359 6KDB54 BV359 6KDB55 BV359 6KDB56 BV359 6KDB57 BV359 6KDB58 BV359
6KDB59 BV359 6KDB60 BV359 6KDB61 BV359 6KDB62 BV359 6KDB63 BV359 6KDB64 BV359 6KDB65
BV359 6KDB66 BV359 6KDB67 BV359 6KDB68 BV359 6KDB69 BV359 6KDB70 BV359 6KDB71
BV359 6KDB72 BV359 6KDB73 BV359 6KDB74 BV359 6KDB75 BV359 6KDB76 BV359 6KDB77
BV359 6KDB78 BV359 6KDB79 BV359 6KDB80 BV359 6KDB81 BV359 6KDB82 BV359 6KDB83
BV359 6KDB84 BV359 6KDB85 BV359 6KDB86 BV359 6KDB87 BV359 6KDB88 BV359
Count
275 BVR-150S 6KBP34 BVR-150S 6KBP35 BVR-150S 6KBP36 BVR-150S 6KBP37 BVR-150S
6KBP38 BVR-150S 6KBP39 BVR-150S 6KBP40 BVR-150S
Count
7 BVR-160M 6GPX01 BVR-160M 6GPX02 BVR-160M 6GPX03 BVR-160M 6GWF01 BVR-160M
6GWF02 BVR-160M 6GWF03 BVR-160M 6GWF04 BVR-160M 6GWF05 BVR-160M 6GWF06 BVR-160M
6GWF07 BVR-160M 6GWF08 BVR-160M 6GWF09 BVR-160M 6GWF11 BVR-160M 6GWF12 BVR-160M
6GWF13 BVR-160M 6GWF14 BVR-160M 6GWF15 BVR-160M 6GWF16 BVR-160M 6GWF17 BVR-160M
6GWF18 BVR-160M 6GWF19 BVR-160M 6GWF20 BVR-160M 6GWF21 BVR-160M 6GWF22 BVR-160M
6GWF23 BVR-160M 6GWF24 BVR-160M 6GWF25 BVR-160M 6GWF26 BVR-160M 6GWF27 BVR-160M
6GWF28 BVR-160M 6GWF29 BVR-160M 6GWF30 BVR-160M 6GWF31 BVR-160M 6GWF32 BVR-160M
6GWF33 BVR-160M 6GWF34 BVR-160M 6GWF35 BVR-160M 6GWF36 BVR-160M 6GWF37 BVR-160M
6GWF38 BVR-160M 6GWF39 BVR-160M 6GWF40 BVR-160M 6GWF41 BVR-160M 6GWF42 BVR-160M
6GWF43 BVR-160M 6GWF44 BVR-160M 6GWF46 BVR-160M 6GWF47 BVR-160M 6GWF48 BVR-160M
6GWF49 BVR-160M 6GWF50 BVR-160M 6GWF51 BVR-160M 6GWF52 BVR-160M 6GWF53 BVR-160M
6GWF54 BVR-160M 6GWF55 BVR-160M 6GWF56 BVR-160M 6GWF57 BVR-160M 6GWF58 BVR-160M
6GWF59 BVR-160M 6GWF60 BVR-160M 6GWF61 BVR-160M 6GWF62 BVR-160M 6GWF63 BVR-160M
6GWF64 BVR-160M 6GWF65 BVR-160M 6GWF66 BVR-160M 6GWF67 BVR-160M 6GWF68 BVR-160M
6GWF69 BVR-160M 6GWF70 BVR-160M 6GWF71 BVR-160M 6GWF72 BVR-160M 6GWF74 BVR-160M
6GWF75 BVR-160M 6GWF76 BVR-160M 6GWF77 BVR-160M 6GWF78 BVR-160M 6GWF79 BVR-160M
6GWF80 BVR-160M 6GWF81 BVR-160M 6GWF82 BVR-160M 6GWF83 BVR-160M
Count
83CEN55F 6C5R66 CEN55F 6C5R67 CEN55F 6C5R68 CEN55F 6C5R69 CEN55F 6C5R70 CEN55F
6C5R71 CEN55F 6C5R72 CEN55F 6C5R74 CEN55F 6C5W01 CEN55F 6C5W02 CEN55F 6C5W03
CEN55F 6C5W04 CEN55F 6C5W05 CEN55F 6C5W06 CEN55F 6C5W07
CEN55F
6C5W08 CEN55F 6C5W09 CEN55F 6C5W10 CEN55F 6C5W11 CEN55F 6C5W12 CEN55F 6C5W13
CEN55F
Count
21 EB33B 6KKT02 EB33B 6KKT05 EB33B 6KKT06 EB33B 6KKT07 EB33B 6KKT09 EB33B
6KKT10 EB33B 6KKT11 EB33B 6KKT12 EB33B 6KKT13 EB33B 6KKT14 EB33B
Count
10 EZE-50 6J1R01 EZE-50 6J1R02 EZE-50 6J1R03 EZE-50 6J1R04 EZE-50 6J1R05 EZE-50
6J1R06 EZE-50 6J1R07 EZE-50 6J1R09 EZE-50 6J1R10 EZE-50 6J1R11 EZE-50 6J1R12
EZE-50 6J1R13 EZE-50 6J1R14 EZE-50 6J1R15 EZE-50 6J1R18 EZE-50 6J1R19 EZE-50
6J1R20 EZE-50 6LVD01 EZE-50 6LVD02 EZE-50 6LVD03 EZE-50 6LVD04 EZE-50 6LVD05
EZE-50 6LVD06 EZE-50
Count
23 FL652F 6C7C01 FL652F 6C7C02 FL652F 6CUH01 FL652F 6CUH02 FL652F 6CUH03 FL652F
6CUH04 FL652F 6CUH05 FL652F 6CUH06 FL652F 6CUH07 FL652F 6CUH08 FL652F 6CUH09
FL652F
Count
11 FL65LF 6CUJ06 FL65LF 6CUJ07 FL65LF
Count
2 I0359 6BUT02 I0359 6BUT18 I0359
Count
2 MIC6 6CV901 MIC6
Count
1 MIC6F 6CFL01 MIC6F 6CFL02 MIC6F 6CFL03 MIC6F 6CFL04 MIC6F 6CFL05 MIC6F 6CFL06
MIC6F 6CFL07 MIC6F 6CFL08 MIC6F 6CFL09 MIC6F 6CFL10 MIC6F 6CV703 MIC6F 6CV704
MIC6F 6CV802 MIC6F 6CV803 MIC6F 6CV804 MIC6F 6CV805 MIC6F 6CV806 MIC6F 6CV807
MIC6F 6CV808 MIC6F 6CV809 MIC6F 6CV810 MIC6F 6CV811 MIC6F 6CV812 MIC6F 6CV813
MIC6F 6DAR02 MIC6F 6DAR03 MIC6F 6DAR04 MIC6F 6DAR07 MIC6F 6DAR08 MIC6F 6DAR09
MIC6F 6DAR10 MIC6F 6DAR12 MIC6F 6DAT02 MIC6F 6DAT03 MIC6F 6DAT04 MIC6F 6DAT05
MIC6F 6DAT06 MIC6F 6DAT07 MIC6F 6DAT08 MIC6F 6DAT09 MIC6F 6DAT10 MIC6F 6DAT11
MIC6F 6DAT12 MIC6F 6DAT13 MIC6F 6DAT14 MIC6F 6DAT15 MIC6F 6DAT16 MIC6F 6DAT17
MIC6F 6DAT18 MIC6F 6DAT19 MIC6F 6DAT20 MIC6F 6DAT21 MIC6F 6DAT22 MIC6F 6DAT23
MIC6F 6DAT24 MIC6F 6DAT25 MIC6F 6DAT26 MIC6F 6DAT27 MIC6F 6DAT28 MIC6F 6DAT29
MIC6F
6DAT30 MIC6F 6DAT31 MIC6F 6DAT32 MIC6F 6DAT33 MIC6F 6DAT34 MIC6F 6DAT35 MIC6F
6DAT36 MIC6F 6DAT37 MIC6F 6DAT38 MIC6F 6DAT69 MIC6F 6DAT70 MIC6F 6DAT71 MIC6F
6DAT72 MIC6F 6DAT73 MIC6F 6DAT74 MIC6F 6DAT76 MIC6F 6DAT77 MIC6F 6DAT78 MIC6F
6DAT79 MIC6F 6DAT80 MIC6F 6DAT81 MIC6F 6DAT82 MIC6F 6DAT83 MIC6F 6DAT84 MIC6F
6DAT85 MIC6F 6DAT86 MIC6F 6DAT87 MIC6F 6DAT88 MIC6F 6DAT89 MIC6F 6DAT90 MIC6F
6DAT91 MIC6F 6DAT94 MIC6F 6DAW01 MIC6F 6DAW02 MIC6F 6DAW33 MIC6F 6DAW34 MIC6F
6DAW35 MIC6F 6DAW36 MIC6F 6DAW37 MIC6F 6DAW38 MIC6F 6DAW39 MIC6F 6DAW40 MIC6F
6DAW41 MIC6F 6DAW42 MIC6F 6DAW43 MIC6F 6DAW44 MIC6F 6DAW45 MIC6F 6DAW46 MIC6F
6DAW47 MIC6F 6DAW48 MIC6F 6DAW49 MIC6F 6DAW50 MIC6F 6DAW51 MIC6F 6DAW52 MIC6F
6DAW53 MIC6F 6DAW54 MIC6F 6DAW55 MIC6F 6DAW56 MIC6F
Count
118 P328UV 6JAG01 P328UV 6JAG02 P328UV 6JAG03 P328UV 6JAG04 P328UV 6JAG05
P328UV 6JAG06 P328UV 6JAG07 P328UV 6JAG08 P328UV 6JAG09 P328UV 6JAG10 P328UV
6JAG11 P328UV 6JAG12 P328UV 6JAG13 P328UV 6KC701 P328UV 6KC702 P328UV 6KC703
P328UV 6KC704 P328UV 6KC705 P328UV 6KC706 P328UV 6KC707 P328UV 6KC708 P328UV
6KC709 P328UV 6KC710 P328UV 6KC711 P328UV 6KC712 P328UV 6KC713 P328UV 6KC714
P328UV 6KC715 P328UV 6KCW01 P328UV 6KCW02 P328UV 6KCW03 P328UV 6KCW04 P328UV
6KCW05 P328UV 6KCW06 P328UV 6KCW07 P328UV 6KCW08 P328UV 6KCW09 P328UV 6KCW10
P328UV 6KCW11 P328UV 6KCW12 P328UV 6KCW13 P328UV
Count
41 P329UV 6MFM01 P329UV 6MFM02 P329UV 6MFM03 P329UV 6MFM04 P329UV 6MFM05 P329UV
6MFM06 P329UV 6MFM07 P329UV 6MFM11 P329UV 6MFM12 P329UV 6MFM13 P329UV 6MFM14
P329UV 6MFN33 P329UV 6MFN34 P329UV 6MFN35 P329UV 6MFN36 P329UV 6MFN37 P329UV
6MFN38 P329UV 6MFN39 P329UV 6MFN40 P329UV 6MFN41 P329UV 6MFN42 P329UV 6MFN43
P329UV 6MFN44 P329UV 6MFN45 P329UV 6MFN46 P329UV 6MFN47 P329UV 6MFN48 P329UV
6MFN49 P329UV 6MFN50 P329UV 6MFN51
P329UV
6MFN52 P329UV 6MFN53 P329UV 6MFN54 P329UV 6MFN55 P329UV 6MFN56 P329UV 6MFN57
P329UV 6MFN58 P329UV 6MFN59 P329UV 6MFN60 P329UV 6MFN61 P329UV 6MFN62 P329UV
6MFN63 P329UV 6MFN64 P329UV 6MFN65 P329UV 6MFN66 P329UV 6MFN67 P329UV 6MFN68
P329UV 6MFN69 P329UV 6MFN70 P329UV 6MFN71 P329UV 6MFN72 P329UV 6MFU01 P329UV
6MFU02 P329UV 6MFU03 P329UV 6MFU04 P329UV 6MFU05 P329UV 6MFU06 P329UV 6MFU07
P329UV 6MFU08 P329UV 6MFU09 P329UV 6MFU10 P329UV 6MFW01 P329UV 6MFW02 P329UV
6MFW03 P329UV 6MFW04 P329UV 6MFW05 P329UV 6MFW06 P329UV 6MFW07 P329UV 6MFW08
P329UV 6MFW09 P329UV 6MFW10 P329UV 6MFW11 P329UV 6MFW12 P329UV 6MFW15 P329UV
6MFW16 P329UV 6MFW17 P329UV Count76 P337UV
6KB001 P337UV 6KB002 P337UV 6KB003 P337UV 6KB004 P337UV 6KB005 P337UV 6KB006
P337UV 6KB007 P337UV 6KB008 P337UV 6KB009 P337UV 6KB010 P337UV 6KB011 P337UV
6KB012 P337UV 6KB013 P337UV 6KB014 P337UV 6KB015 P337UV 6KB016 P337UV 6KB017
P337UV 6KB033 P337UV 6KB034 P337UV 6KB035 P337UV 6KB036 P337UV 6KB037 P337UV
6KB038 P337UV
Count
23 P356UV 6CF118 P356UV 6CF119 P356UV
Count
2 P359UV 6KB401 P359UV 6KB464 P359UV 6KB465 P359UV 6KB466 P359UV 6KB467 P359UV
6KB468 P359UV 6KB469 P359UV 6KB470 P359UV 6KB471 P359UV 6KB472 P359UV 6KB473
P359UV 6KB474 P359UV 6KC401 P359UV 6KC402 P359UV 6KC405 P359UV 6KC406 P359UV
6KC407 P359UV 6KC408 P359UV 6KC409 P359UV 6KC410 P359UV 6KC411 P359UV 6KC412
P359UV
Count
22 P366UV 6CGP01 P366UV 6CWX02 P366UV 6CWX05 P366UV 6CWX06 P366UV 6CWX07 P366UV
6CWX09 P366UV 6CWX13 P366UV 6CWX22 P366UV 6CWX23 P366UV 6CWX24 P366UV 6CWX25
P366UV 6CWX26 P366UV 6CWX28 P366UV 6CWX35 P366UV 6CWX40P366UV 6CWX46 P366UV
Count
16 P379UV 6DXC32 P379UV 6DXC33 P379UV 6DXC34 P379UV 6DXC35 P379UV 6DXC36 P379UV
6DXC37 P379UV 6DXC38 P379UV 6DXC39 P379UV
Count
8 P492UV 6KC801 P492UV 6KC802 P492UV 6KC803 P492UV 6KC804 P492UV 6KC805 P492UV
6KC806 P492UV 6KC807 P492UV 6KC808 P492UV 6KC809 P492UV 6KC810 P492UV 6KC811
P492UV 6KC812 P492UV 6KC813 P492UV 6KC815 P492UV 6KC816 P492UV 6KC817 P492UV
6KC818 P492UV 6KC819 P492UV 6KC820 P492UV 6KC821 P492UV 6KC822 P492UV 6KC823
P492UV 6KC832 P492UV 6KC833 P492UV 6KC834 P492UV 6KC835 P492UV 6KC836 P492UV
6KC837 P492UV 6KC838 P492UV 6KC839 P492UV 6KC840 P492UV 6KCY01 P492UV 6KCY02
P492UV 6KCY03 P492UV 6KCY05 P492UV 6KCY06 P492UV 6KCY07 P492UV 6KCY08 P492UV
6KCY09 P492UV 6KCY10 P492UV 6KCY11 P492UV 6KCY12 P492UV 6KCY13 P492UV
Count
43 P499UV 6DBL01 P499UV 6DBL02 P499UV 6KC201 P499UV
Count
3 P506UV 6ETY01 P506UV 6ETY04 P506UV 6ETY07 P506UV 6ETY08 P506UV 6ETY10 P506UV
6ETY11 P506UV 6ETY12 P506UV 6ETY14 P506UV 6ETY16 P506UV 6ETY20 P506UV 6ETY21
P506UV 6ETY22 P506UV 6ETY24 P506UV 6ETY25 P506UV 6ETY28 P506UV 6J1J01 P506UV
6J1J02 P506UV 6J1J03 P506UV 6J1J04 P506UV 6KWJ01 P506UV 6KWJ02 P506UV
Count
21 PERLN2 6CWD01 PERLN2 6CWD02 PERLN2 6CWD03 PERLN2 6CWD04 PERLN2 6CWD05 PERLN2
6CWD06 PERLN2 6CWD07 PERLN2 6CWD10 PERLN2 6CWD12 PERLN2 6CWE01 PERLN2 6CWE02
PERLN2 6CWE03 PERLN2 6CWE04 PERLN2 6CWE05 PERLN2 6CWE06 PERLN2 6CWE07 PERLN2
6DBG01 PERLN2 6DBG02 PERLN2 6DBG07 PERLN2 6DBG08 PERLN2 6DBG11 PERLN2 6DBG13
PERLN2 6DBH01 PERLN2 6DBH02 PERLN2 6DBH03 PERLN2 6DBH04 PERLN2 6DBH05 PERLN2
6DBH06 PERLN2 6DBH07 PERLN2 6DBH08
PERLN2
6DBH09 PERLN2 6DBH11 PERLN2 6DBH13 PERLN2 6DBH14 PERLN2 6DBH15 PERLN2 6DBH16
PERLN2 6DBH17 PERLN2 6DBK01 PERLN2 6DBK06 PERLN2 6KXW01 PERLN2 6KXY01 PERLN2
6KXY03 PERLN2
Count
42 PERLN2F 6CWA01 PERLN2F 6CWA02 PERLN2F 6CWA03 PERLN2F 6CWA04 PERLN2F 6CWA05
PERLN2F 6CWA06 PERLN2F 6CWA07 PERLN2F 6CWA08 PERLN2F 6CWA09 PERLN2F 6CWA10
PERLN2F 6CWC01 PERLN2F 6DA836 PERLN2F 6DA837 PERLN2F
6DA838
PERLN2F 6DA839 PERLN2F 6DA843 PERLN2F 6DA845 PERLN2F 6DA846 PERLN2F 6DA847
PERLN2F 6DA848 PERLN2F 6DA849 PERLN2F 6DA850 PERLN2F 6DA851 PERLN2F 6DA852
PERLN2F 6DA853 PERLN2F 6DA854 PERLN2F 6DA855 PERLN2F 6DA856 PERLN2F 6DA857
PERLN2F 6DA860 PERLN2F 6DA861 PERLN2F
Count
31 PSM3 1001808001 PSM3 1001808002 PSM3 1001808003 PSM3 1001808004 PSM3 1001808005 PSM3 1001808006 PSM3
1001808007 PSM3 1001808008 PSM3 1001808009 PSM3 1001808010 PSM3 1001808011 PSM3
1001808012 PSM3 1001808013 PSM3 1001808014 PSM3 1001808015 PSM3 1001808016 PSM3
1001808017 PSM3 1001808018 PSM3 1001808033 PSM3 1001808034 PSM3 1001808035 PSM3
1001808036 PSM3 1001808037 PSM3 1001808038 PSM3 1001808039 PSM3 1001808040 PSM3
1001808041 PSM3 1001808042 PSM3 1001808043 PSM3 1001808044 PSM3 1001808045 PSM3
1001808046 PSM3 1001808047 PSM3 1001808048 PSM3 1001808049 PSM3 1001808050 PSM3
1001808051 PSM3 1001808052 PSM3 1001808053 PSM3 1001808054 PSM3 1001808055 PSM3
1001808056 PSM3 1001808058 PSM3 1001808059 PSM3 1001808060 PSM3 1001808061 PSM3
1001808062 PSM3 1001808063 PSM3 1001808064 PSM3 1001808065 PSM3 1001812001 PSM3
1001812002
PSM3
1001812003 PSM3 1001812004 PSM3 1001812005 PSM3 1001812006 PSM3 1001812007 PSM3
1001812008 PSM3 1001812009 PSM3 1001812010 PSM3 1001812011 PSM3 1001812012 PSM3
1001812013 PSM3 1001812014 PSM3 1001812015 PSM3 1001812016 PSM3 1001812017 PSM3
1001812018 PSM3 1001812019 PSM3 1001812020 PSM3 1001812021 PSM3 1001812022 PSM3
1001812023 PSM3 1001812024 PSM3 1001812025 PSM3 1001812026 PSM3 1001812027 PSM3
1001812028 PSM3 1001812029 PSM3 1001812030 PSM3 1001812031 PSM3 1001812032 PSM3
1001812033 PSM3 1001812034 PSM3 1001812035 PSM3 1001812036 PSM3 1001812037 PSM3
1001815001 PSM3 1001815002 PSM3 1001815003 PSM3 1001815004 PSM3 1001815005 PSM3
1001815006 PSM3 1001815007 PSM3 1001815008 PSM3 1001815009 PSM3 1001815010 PSM3
1001815011 PSM3 1001815012 PSM3 1001815013 PSM3 1001815014 PSM3 1001815015 PSM3
1001815016 PSM3 1001815017 PSM3 1001815018 PSM3 1001815019 PSM3 1001815020 PSM3
1001815021 PSM3 1001815022 PSM3 1001815023 PSM3 1001815024 PSM3 1001815025
PSM3
1001815026 PSM3 1001815027 PSM3 1001815028 PSM3 1001815029 PSM3 1001815030 PSM3
1001815031 PSM3 1001815032 PSM3 1001815033 PSM3 1001815034 PSM3 1001815035 PSM3
1001815036 PSM3 1001815037 PSM3 1001815038 PSM3 1001815039 PSM3 1001815040 PSM3
1001815041 PSM3 1001815042 PSM3 1001815043 PSM3 1001815044 PSM3 1001815045 PSM3
1001815046 PSM3 1001815047 PSM3 1001815048 PSM3 1001815049 PSM3 1001815050 PSM3
1001815051 PSM3 1001815052 PSM3 1001815053 PSM3 1001815055 PSM3 1001815056 PSM3
1001815057 PSM3 1001815058 PSM3 1001815059 PSM3 1001815060 PSM3 1001815061 PSM3
1001815062 PSM3 1001815063 PSM3 1001815064 PSM3 1001815065 PSM3 1001815066 PSM3
1001815067 PSM3 1001815068 PSM3 1001815069 PSM3 1001815070 PSM3 1001815071 PSM3
1001815072 PSM3 1001815073 PSM3 1001815074 PSM3 1001815075 PSM3 1001815076 PSM3
1001815077 PSM3 1001815078 PSM3 1001815079 PSM3 1001815080 PSM3 1001815081 PSM3
1001815082 PSM3 1001815083 PSM3 1001815084 PSM3 1001815085 PSM3 1001815086
PSM3
1001815087 PSM3 1001815088 PSM3 1001815089 PSM3 1001815090 PSM3 1001817001 PSM3
1001817002 PSM3 1001817003 PSM3 1001817004 PSM3 1001817005 PSM3 1001817006 PSM3
1001817007 PSM3 1001817008 PSM3 1001817009 PSM3 1001817010 PSM3 1001817011 PSM3
1001817012 PSM3 1001817013 PSM3 1001817014 PSM3 1001817015 PSM3 1001817016 PSM3
1001817017 PSM3 1001817018 PSM3 1001817019 PSM3 1001817020 PSM3 1001817021 PSM3
1001817022 PSM3 1001817023 PSM3 1001817024 PSM3 1001817025 PSM3 1001817026 PSM3
1001817027 PSM3 1001817028 PSM3 1001817029 PSM3 1001817030 PSM3 1001817031 PSM3
1001817032 PSM3 1001817033 PSM3 1001817034 PSM3 1001817035 PSM3 1001817036 PSM3
1001817037 PSM3 1001817038 PSM3 1001817039 PSM3 1001817040 PSM3 1001817041 PSM3
1001817042 PSM3 1001817043 PSM3 1001817044 PSM3 1001817045 PSM3 1001817046 PSM3
1001817047 PSM3 1001817048 PSM3 1001817049 PSM3 1001817050 PSM3 1001817051 PSM3
1001817052 PSM3 1001817053 PSM3 1001817054 PSM3 1001817055 PSM3 1001817056
PSM3
1001817057 PSM3 1001817058 PSM3 1001817059 PSM3 1001817060 PSM3 1001817061 PSM3
1001817062 PSM3 1001817063 PSM3 1001817064 PSM3 1001817065 PSM3 1001817066 PSM3
1001817067 PSM3 1001817068 PSM3 1001817069 PSM3 1001817070 PSM3 1001817071 PSM3
1001817072 PSM3 1001817073 PSM3 1001817074 PSM3 1001817075 PSM3 1001817076 PSM3
1001817077 PSM3 1001817078 PSM3 1001817079 PSM3 1001817080 PSM3 1001817081 PSM3
1001817082 PSM3 1001817083 PSM3 1001817084 PSM3 1001817085 PSM3 1001817086 PSM3
1001817087 PSM3 1001817088 PSM3 1001817089 PSM3 1001817090 PSM3 1001817091 PSM3
1001820002 PSM3 1001820003 PSM3 1001820006 PSM3 1001820007 PSM3 1001820009 PSM3
1001820010 PSM3 1001820011 PSM3 1001820012 PSM3 1001820013 PSM3 1001820014 PSM3
1001820015 PSM3 1001820016 PSM3 1001820017 PSM3 1001820018 PSM3 1001820019 PSM3
1001820020 PSM3 1001820021 PSM3 1001823001 PSM3 1001823002 PSM3 1001823003 PSM3
1001823004 PSM3 1001823005 PSM3 1001823006 PSM3 1001823007 PSM3 1001823008
PSM3
1001823009 PSM3 1001823010 PSM3 1001823011 PSM3 1001823012 PSM3 1001823013 PSM3
1001823014 PSM3 1001823015 PSM3 1001823016 PSM3 1001823017 PSM3 1001823018 PSM3
1001823019 PSM3 1001823020 PSM3 1001823021 PSM3 1001823022 PSM3 1001823023 PSM3
1001823024 PSM3 1001823025 PSM3 1001823026 PSM3 1001823027 PSM3 1001823028 PSM3
1001823029 PSM3 1001823030 PSM3 1001823031 PSM3 1001823032 PSM3 1001823033 PSM3
1001823034 PSM3 1001823035 PSM3 1001823036 PSM3 1001823037 PSM3 1001823038 PSM3
1001829001 PSM3 1001829002 PSM3 1001829003 PSM3 1001829004 PSM3 1001829005 PSM3
1001829006 PSM3 1001829007 PSM3 1001829008 PSM3 1001829009 PSM3 1001829010 PSM3
1001829011 PSM3 1001829012 PSM3 1001829013 PSM3 1001829014 PSM3 1001829015 PSM3
1001829016 PSM3 1001829017 PSM3 1001829018 PSM3 1001829019 PSM3 1001829020 PSM3
1001829021 PSM3 1001829022 PSM3 1001829023 PSM3 1001829024 PSM3 1001829025 PSM3
Count
347 S122UV 6CXF01 S122UV 6CXF03 S122UV 6CXF04 S122UV 6CXF05 S122UV 6CXF06
S122UV 6CXF07 S122UV 6CXF08 S122UV 6CXF09 S122UV 6CXF10 S122UV 6CXF11 S122UV
6CXF12 S122UV 6CXF13 S122UV 6CXF14 S122UV 6CXF15 S122UV 6CXF16 S122UV 6CXF17
S122UV 6CXF18 S122UV 6CXF19 S122UV 6CXF20 S122UV 6CXF21 S122UV 6CXF22 S122UV
6CXF23 S122UV 6CXF24 S122UV 6CXF25 S122UV 6CXF26 S122UV 6CXF27 S122UV 6CXF28
S122UV 6CXF29 S122UV 6CXF30 S122UV 6CXF31 S122UV 6CXF32 S122UV 6CXF33 S122UV
6CXF34 S122UV 6CXF35 S122UV 6CXF36 S122UV 6CXF37 S122UV 6CXF38 S122UV 6CXF39 S122UV
6CXF40 S122UV 6CXF41 S122UV 6CXF42 S122UV 6CXF43 S122UV 6CXF44 S122UV 6CXF45
S122UV 6CXF46 S122UV 6CXF49 S122UV 6CXF50 S122UV 6CXF51 S122UV 6CXF54 S122UV
6CXF55 S122UV 6CXF57 S122UV 6CXF59 S122UV 6CXF60 S122UV 6CXF61 S122UV 6CXF62
S122UV 6CXF63 S122UV 6CXF65 S122UV 6CXF66 S122UV 6CXF67 S122UV 6CXF70 S122UV
6CXF72 S122UV 6CXF73 S122UV 6CXF74 S122UV 6CXF75 S122UV 6CXF76 S122UV 6CXF79
S122UV 6CXF81 S122UV 6CXF82 S122UV 6DXK01 S122UV 6DXK03 S122UV 6DXK04 S122UV
6DXK05 S122UV 6DXK06 S122UV 6DXK07 S122UV 6DXK08 S122UV 6DXK10 S122UV 6DXK11
S122UV 6DXK12 S122UV 6DXK13 S122UV 6DXK15 S122UV 6DXK16 S122UV 6DXK17 S122UV
6DXK18 S122UV 6DXK19 S122UV 6DXK20 S122UV 6DXK21 S122UV 6DXK22 S122UV 6DXK23
S122UV 6DXK24 S122UV 6DXK25 S122UV 6DXK26 S122UV 6DXK27 S122UV 6DXK28 S122UV
6DXK30 S122UV 6DXK43 S122UV 6DXK44 S122UV 6DXK45 S122UV 6DXK46 S122UV 6DXK47
S122UV 6DXK48 S122UV 6DXK49 S122UV 6DXK50 S122UV 6DXK51 S122UV 6DXK52 S122UV
6DXK53 S122UV 6DXK55 S122UV 6DXM01 S122UV 6DXM02 S122UV 6DXM03 S122UV 6DXM05
S122UV 6DXM06 S122UV 6DXM07 S122UV 6DXM08 S122UV 6DXM09 S122UV 6DXM10 S122UV
6DXM11 S122UV 6DXM12 S122UV 6DXM13 S122UV 6DXM14 S122UV 6DXM15 S122UV 6DXM16
S122UV 6DXM17 S122UV 6DXM18 S122UV 6DXM19 S122UV 6DXM21 S122UV 6DXP01 S122UV
6DXP02 S122UV 6DXP03 S122UV 6DXP04 S122UV 6DXP05 S122UV 6DXP06 S122UV 6DXP07
S122UV 6DXP08 S122UV 6DXP11 S122UV 6DXP12 S122UV 6DXP13 S122UV 6DXP14 S122UV
6DXP15 S122UV 6DXP16 S122UV 6DXP17 S122UV 6DXP18 S122UV 6DXP19 S122UV 6DXP21
S122UV 6DXP22 S122UV 6DXP24 S122UV 6DXP25 S122UV 6DXP26 S122UV 6DXP27 S122UV
6DXP28 S122UV 6DXR01
S122UV
6DXR02 S122UV 6DXR03 S122UV 6DXR04 S122UV 6DXR05 S122UV 6DXR06 S122UV 6DXR07
S122UV 6DXR08 S122UV 6DXR09 S122UV 6DXR10 S122UV 6DXR11 S122UV 6DXR12 S122UV
6DXR13 S122UV 6DXR14 S122UV 6DXR15 S122UV 6DXR16 S122UV 6DXR17 S122UV 6KDL01
S122UV 6KDL02 S122UV 6KDL03 S122UV 6KDL04 S122UV 6KDL05 S122UV 6KDL06 S122UV
6KDL07 S122UV 6KDL08 S122UV 6KDL09 S122UV 6KDL10 S122UV 6KDL11 S122UV 6KDL12
S122UV 6KDL13 S122UV 6KDL14 S122UV 6KDL15 S122UV 6KDL16 S122UV 6KDL17 S122UV
6KDL18 S122UV 6KDL19 S122UV 6KDL20 S122UV 6KDL21 S122UV 6KDL22 S122UV 6KDL23
S122UV 6KDL24
S122UV
6KDL25 S122UV 6KDL26 S122UV 6KDL27 S122UV 6KDL28 S122UV 6KDL29 S122UV 6KDL30
S122UV 6KDL31 S122UV 6KDL32 S122UV 6KDL33 S122UV 6KDL34 S122UV 6KDL35 S122UV
6KDL36 S122UV 6KDL38 S122UV 6KDL41 S122UV 6KDL42 S122UV 6KDL43 S122UV 6KDL44
S122UV 6KDL45 S122UV 6KDL46 S122UV 6KDL47 S122UV 6KDL48 S122UV 6KDM01 S122UV
6KDM02 S122UV 6KDM03 S122UV 6KDM04 S122UV 6KDM05 S122UV 6KDM06 S122UV 6KDM07
S122UV 6KDM08 S122UV 6KDM09 S122UV 6KDM10 S122UV 6KDM11 S122UV 6KDM12 S122UV
6KDM13 S122UV 6KDM14 S122UV 6KDM15 S122UV 6KDM16 S122UV 6KDM17 S122UV 6KDM18
S122UV 6KDM19 S122UV 6KDM20 S122UV
Count
231 SIFL2 6EWF97 SIFL2 6EWF98 SIFL2
Count
2 Z130 6KKU01 Z130 6KKU02 Z130
Count
2 Grand Count 1639
REASON: Possible compromise of sterility packaging
barriers.
MANUFACTURER/RECALLING FIRM: BAUSCH & LOMB
SURGICAL, INC., North Clearwater, FL
DISTRIBUTION: Nationwide, International
QUANTITY: 1639
PRODUCT AND CODE: Impervious Labeled,
Internally-Reinforced UltraGard Gowns - The affected gowns are labeled as
"single use only." The
following products/labels are under recall:
Ref.
22321 - X-Lg Impervious Reinforced Gown
Ref.
33311 - Large Impervious Reinforced Gown
Reorder
No. 33311 - Large O.R. Gown
Ref.
33321 - X-Large Impervious Reinforced Gown
Reorder
No. 33321 - X-Large O.R. Gown
Ref.
33331 - XX-Large Impervious Reinforced Gown
Reorder
No. 33331 - XX-Large O.R. Gown
Ref.
33950 - Lg Impervious Reinforced Gown
Reorder
No. 33950 - Large O.R. Gown
Ref.
33960 - X-Lg Impervious Reinforced Gown
Reorder
No. 33960 - X-Large O.R. Gown
Reorder
No. 33970 - X-Large X-Long O.R. Gown
Reorder
No. 44062 - Arthroscopy Pack
Reorder
No. 44110 - Basic Pack
Reorder
No. 44116 - Basic Pack
Reorder
No. 44223 - Laparotomy Pack
Reorder
No. 44224 - Laparotomy Pack
Reorder
No. 44460 - Shoulder Arthroscopy Pack
Reorder
No. 44464 - Hip Pack
Reorder
No. 44465 - General Orthopedic Pack
Reorder
No. 44466 - Hip Pack
Reorder
No. 44468 - Arthroscopy Pack
Reorder
No. 44469 - Extremity Pack
Reorder
No. 44473 - CV Pack
Reorder
No. 44481 - Arthroscopy Pack
Reorder
No. 44541 - Lithotomy Pack IV
Reorder
No. 44773 - E.E.N.T. Ultra Pack
Reorder
No. 44775 - CV Pack
Reorder
No. 44787 - Femoral Angio Pack
Reorder
No. 45118 - Scoleosis Pack
Reorder
No. 47777 - Femoral Angio Pack
Ref.
70311 - Large Zoned Impervious Gown
Ref.
70321 - X-Lg Zoned Impervious Gown
Ref.
92039 - Large Ultragard Impervious Reinforced Gown
Reorder
No. 92039 - Large O.R. Gown
Ref.
92043 - X-Lg Zoned Impervious Gown
Reorder
No. 92043 - X-Large O.R. Gown
Ref.
92046 - XX-Lg Zoned Impervious Gown
Reorder
No. 92046 - XX-Large O.R Gown
Ref.
95311 - Large Zoned Impervious Gown
Reorder
No. 95311 - Large O.R. Gown
Ref.
95321 - X-Lg Zoned Impervious Gown
Reorder
no. 95321 - X-Large O.R. Gown
Ref.
95331 - XX-Lg Zoned Imperious Gown
Reorder
No., 95331 - XX-large O.R. Gown
Ref.
16-8950 - Lge Impervious Reinforced Gown
Ref.
16-8960 X-Lg Impervious Reinforced Gown
Some
of the products are for bulk, non-sterile components that are intended for use
in finished surgical kit devices made by others.
Code:
992710, 992870, 992920, 992950, 993000, 993010, 993140, 993200, 993210, 993230,
993300, 993420, 993430, 993490, 993510, 1000050,
1000120,
1000190, 1000200, 1000250, 1000260, 1000270, 1000310, 1000350, 1000410,
1000450, 1000470, 1000480, 1000540, 1000660, 1000670, 1000680, 1000690,
1000700, 1000740, 1000750, 1000760, 1000770, 1000840, 1000880, 1000910,
1000970, 1000980, 1000990, 1000970, 1000980, 1000990, 1001020, 1001030,
1001040, 1001050, 1001060, 1001080, 1001090, 1001100, 1001160, 1001170,
1001180, 1001240, 1001250, 1001290, 1001300, 1001330, 1001390, 1001400,
1001430, 1001440, 1001450, 1001460, 1001470, 1001500, 1001510, 1001520,
1001530, 1001580, 1001590, 1001600, 1001610, 1001650, 1001660, 1001670,
1001680, 1001710, 1001720, 1001730, 1001740, 1001750, 1001780, 1001790,
1001800, 1001820, 1001850, 1001860, 1001870, 1001890, 1001920, 1001930,
1001960, 1002010, 1002020, 1002030, 1002070, 1002080, 1002100, 1002130,
1002140, 1002150, 1002160, 1002170, 1002210, 1002230, 1002240, 1002270,
1002290, 1002300, 1002310, 1002340, 1002350, 1002360, 1002370, 1002380,
1002420,
1002430, 1002440, 1002450, 1002480, 1002500, 1002520, 1002550, 1002560,
1002580, 1002630, 1002640, 1002650, 1002660, 1002690, 1002700, 1002710,
1002760, 1002780, 1002790, 1002800, 1002840, 1002860, 1002870, 1002910,
1002920, 1002930, 1002990, 1003000, 1003010, 1003040, 1003050, 1003060,
1003070, 1003100, 1003120, 1003130, 1003140, 1003150, 1003180, 1003190,
1003200, 1003220, 1003270, 1003280, 1003290, 1003320, 1003350
REASON: Gowns may not be impervious
MANUFACTURER/RECALLING FIRM: White Knight Healthcare,
NC
DISTRIBUTION: Nationwide
QUANTITY: 230,216 gowns or gown packs
PRODUCT AND CODE: gas machine for
anesthesia, Code: 4114586-001
REASON: Reports of unintended PEEP greater than 20 cmH2O,
all occurring at same hospital
MANUFACTURER/RECALLING FIRM: NORTH AMERICAN DRAGER,
Telford, PA
DISTRIBUTION: Nationwide and Canada
QUANTITY: 464 units
PRODUCT AND CODE: Proform Non-Hooded
Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert,
CODE:
Catalog Number SC1163-5052 Lot 3559-071800 1Proform Non-Hooded Acetabular Shell
Liner and Proven Posterior Stabilized Tibial Tray Insert, Catalog Number SC1163-5860
Lot 3600-071800 1Proform Non-Hooded Acetabular Shell Liner and Proven Posterior
Stabilized
Tibial Tray Insert, Catalog Number SC1586-3-10 Lot 3594-071800
REASON: Overlapped seal
MANUFACTURER/RECALLING FIRM: STELKAST CO., Pittsburgh,
PA
DISTRIBUTION: AZ, MI, NC, NY, OH, and PA
QUANTITY: 57 units
PRODUCT AND CODE: 7F BioFlex Tesio Long Term
Hemodialysis or Apheresis Catheter Set, Code Information: Catalog # MCTC730K,
Lot
#M029230
REASON: Mislabeled - incorrect priming volume
MANUFACTURER/RECALLING FIRM: MEDICAL COMPONENTS, INC.,
Harleysville, PA
DISTRIBUTION: CA, FL, IL, MO, NJ, PR, and TX
QUANTITY: 91 Trays
PRODUCT AND CODE: MEDCOMP BIO-FLEX CS
CATHETER (CS100);
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFL-6 - lots: M813770, M819200, M820840,
M902950, M903840, M907780, M915320, M919550, M921320, M929930, M933270 and
M936870.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFL-6CTT (left side) - lots: M912540,
M919140, M932310 and M934780.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFR-6CTT (right side) - lots: M912550,
M915330, M919130, M924550, M932320, M935480, and M937950.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFR-6 - lots: M728810, M801970, M809360,
M813780, M819050, M819980, M820830, M900800, M902960, M903830, M904290,
M904900, M907770, M918790, M918800, M921300, M922780, M924570, M927450,
M933260, M936500, and M937960.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFR-70 - lot: M928700.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFS-6 - lots: M834100, M903280, M912650,
M914740, M927830 and M928340.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #BFS-6CTT - lots: M912560, M931380 and
M932530.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #TRAY 452 - lots: M912380, M916450,
M919100, M924370 and M933050.
MEDCOMP
BIO-FLEX CS CATHETER (CS100) Catalog #TRAY 453 - lot: M912390
REASON: Longitudinal slits
MANUFACTURER/RECALLING FIRM: Medical Components,
Harleysville, PA
DISTRIBUTION: Nationwide and International
QUANTITY: 22876 catheters
PRODUCT AND CODE: Silicone catheters: Tesio
is a long-term hemodialysis catheter.
Schon Duo-Flow is a long-term hemodialysis catheter. Hemo-Cath is a dual
lumen catheter.
CODE:
All lots
REASON: Resent instructions for silicone catheters - not
to use iodine
MANUFACTURER/RECALLING FIRM: MEDICAL COMPONENTS, INC.,
Harleysville, PA
DISTRIBUTION: Nationwide, Austria and Guam
QUANTITY: Unknown
PRODUCT AND CODE: Dimension RxL, Clinical
Chemical Analyzer, RxL/HM with software version 5.1
REASON: Incorrect low results for a number of patient
samples
MANUFACTURER/RECALLING FIRM: DADE BEHRING, INC.,
Newark, DE
DISTRIBUTION: Nationwide & Government & Military.
QUANTITY: 1696 units
PRODUCT AND CODE: Pride Jazzy Scooter. CODE:
model number 1100; Pride Jazzy Scooter.
CODE: model number 1104; Pride Jazzy Scooter, CODE: model number 1120;
Pride Jazzy Scooter. CODE: model number
1170; Pride Jazzy Scooter, CODE: model number PHC1.
REASON: Tire exploded
MANUFACTURER/RECALLING FIRM: PRIDE MOBILITY PRODUCTS
CORP., Exeter, PA
DISTRIBUTION: Nationwide, England, Brazil, China,
Belgium, Italy, Murcia, and Australia
QUANTITY: 61510 units
PRODUCT AND CODE: Dimension RxL integrated
chemistry system. Prostate Specific Antigen (PSA) Flex Reagent Cartridge, CODE:
catalog number RF450. Lots: JS1284 exp. 10/11/01, IP1265 exp. 9/22/01, IR1265
exp. 9/22/01, HN1240 8/28/01, UA1207 exp. 7/26/01, UB1194 exp. 7/13/01, TC1174
exp. 6/23/01, FN1156 exp. 6/5/01, SA1125 exp. 5/5/01, DP1102 exp. 4/12/01,
PC1087 exp. 3/28/01, CP1068 exp. 3/9/01, BM1045 exp. 2/14/01, AR1010 exp.
1/10/01, LS0344 exp. 12/9/00, and KM0327 exp. 11/22/00
REASON: False positive results - increased number
MANUFACTURER:
DADE BEHRING, INC., NEWARK, DE
RECALLED BY: DADE BEHRING, INC., Glasgow, DE
DISTRIBUTION: The product was shipped nationwide &
International to hospitals and medical facilities.
QUANTITY: 10,327 cartons
PRODUCT AND CODE: Stryker Endoscopy brand
5.5mm 6 Flute Barrel Bur , Model Number(s):
(Hooded) 275-951-000)
Stryker
Endoscopy brand 5.5mm 6 Flute Barrel Bur , Model Number(s): (Unhooded)
275-951-200
REASON: The bur tip has a potential to separate from the
bur shaft during surgery.
MANUFACTURER/RECALLING FIRM: STRYKER ENDOSCOPY, Santa
Clara, CA
DISTRIBUTION: Nationwide
QUANTITY: 1175 units
PRODUCT AND CODE: Surgical accessories used
for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high
speed burrs. All products contain a
label that states "SSIS Inc. Date
** Lot # ** Hos Part # ** Part
Description: Sisters, OR ** Product has
been EO Gas sterilized. ***".
Code: 3527
REASON: STERILITY MAY BE COMPROMISED
MANUFACTURER/RECALLING FIRM: Surgical Instrument
Service & Savings, Inc., Sisters, OR
DISTRIBUTION: OR
QUANTITY: 12 pkgs saw blades; 7 high speed burrs, 12 twist
drill bits, 7 burrs
PRODUCT AND CODE: IntraCoil Self-Expanding
Peripheral Endoprosthesis, Model VT640135, Code: Lot Numbers MF1826, MF1827 and
MF1999
REASON: Mislabeled as to french size of the delivery
catheter.
MANUFACTURER/RECALLING FIRM: INTRATHERAPEUTICS, INC.,
St. Paul, MN
DISTRIBUTION: Nationwide
QUANTITY: 38 units
PRODUCT AND CODE: Innova Pelvic Floor
Stimulation System and the touch-proof output jack adapter for the Innova
Pelvic Floor Stimulation System.
CODE:
All Innova units with the old adapter are affected. The Innova was cleared for
market 1/20/95. Innova units were first sold with an adapter on 5/7/00. An
old-style (defective) adapter was provided for all Innova units which were
originally shipped without an adapter prior to 5/7/00. No Innovas were sold
with the old adapter after 9/6/00. The units which have been shipped with the
new adapter are not affected. The new adapter can be identified by the word
Innova which is printed on it. The old "defective" adapters are only
"defective" to the extent that they do not function properly with the
Innova device. They do however function appropriately with the firm's other
devices which include TENS, powered muscle stimulators, and iontophoresis
devices.
REASON: Insufficient electrical contacts in adapter
MANUFACTURER: EMPI, INC., Clear Lake, SD
RECALLED BY: EMPI, INC., ST. PAUL, MN
DISTRIBUTION: Nationwide and Canada
QUANTITY: 191 devices
PRODUCT AND CODE: FlexiLab Laboratory
Information System version 5.3, release date 2/11/2001.
REASON: Wrong normal ranges reported when age is listed as
unknown.
MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION
SYSTEMS, INC., TUCSON, AZ
DISTRIBUTION: AZ, OH, WI, PA, MD, FL, VA, WA and
Washington DC
QUANTITY: 89 sites between 3 recalls
PRODUCT AND CODE: FlexiLab Laboratory
Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic
Pathology Lab Access Transcription Workstation.
REASON: Software glitch
MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION
SYSTEMS, INC., TUCSON, AZ
DISTRIBUTION: Nationwide & worldwide.
QUANTITY: 89 sites between 3 recalls
PRODUCT AND CODE: SIMS Deltec, Inc. Gripper
Port-A-Cath Needle, 0.9 mm (20 G) x 19 mm (3/4 in.), Re-order Number
21-2947-24. Labeled on some individual needle packages as: Z-0728-1, SIMS
Deltec, Inc. Gripper Port-A-Cath Needle, 0.9 mm (20 G) x 25 mm (1 in.),
Re-order Number 21-2948-24. Some of the product has SIMS Graseby Ltd. WD2 4LG
UK as the distributor on the label instead of SIMS Deltec Inc.
CODE:
Lot Number 724X19
REASON: Misidentification of needle length on label.
MANUFACTURER
FIRM: INDUSTRIAS UNIDAS DE BAJA CALIFORNIA, MESA DE OTAY , MEXICO
RECALLED BY: SIMS DELTEC, INC., ST. PAUL, MN
DISTRIBUTION: Nationwide. France, Italy, and UK.
QUANTITY: 2733 shelf boxes (each containing 12 needles)
PRODUCT AND CODE: Model 3625 Test
Stimulator, CODE: S/N# NACO13714P through NACO13717P, NAC013738P through
NAC013749P, NACO13752P through NACO13755P and NACO13759P through NACO13761P
REASON: Reversed labels on amplitude and rate knobs.
MANUFACTURER: MEDTRONIC, MILACA, MN
RECALLED BY: MEDTRONIC, INC., MINNEAPOLIS, MN
DISTRIBUTION: Nationwide
QUANTITY: 23 units
PRODUCT AND CODE:
StatusFlow
Pro CD34 Whole Blood Process Control for Flow
Cytometry
(CD34 positive cells), Code:Lot FC100-34 (StatusFlow Pro),
StatusFlow
Lo CD4-Low Whole Blood Process Control for Flow
Cytometry
(CD4 positive cells), Lot FC100-4L (StatusFlow Lo)
REASON: Values tend to go out of assay range while product
is still within expiration.
MANUFACTURER/RECALLING FIRM: R & D SYSTEMS, INC.,
MINNEAPOLIS, MN
DISTRIBUTION: Nationwide, Australia, France and Germany.
QUANTITY: 79 vials
PRODUCT AND CODE: Behring Coagulation System
(BCS) software version 2.2
REASON: Leak of piston pump valve introduces air bubbles
MANUFACTURER: DADE BEHRING MARBURG,
Germany
RECALLED BY: DADE BEHRING, INC., GLASGOW, DE
DISTRIBUTION: NY, IL, and MI
QUANTITY: 3 units
PRODUCT AND CODE: Five Dimension RxL Flex
Reagent Cartridges. The product is composed of:
1)
Ferritin (FERR)
2)
Human Chorionic Gonadotropic (HCG)
3)
Mass Creatine Kinase MB Isoenzyme (MMB)
4)
Myoglobin
5)
Prostate Specific Antigen (PSA).
FERR
has 120 tests/carton; 30 tests/cartridge. HCG has 120 tests/carton; 30
tests/cartridge. MMB has 160 tests/carton; 40 tests/cartridge. MYO has 120
tests/carton; 30 tests/cartridge. PSA has 120 tests/carton; 30 tests/cartridge
The product is sold by the cartridge or 4 cartridges per carton.
CODE:
FERR Lot FR9351 exp. 12/17/99, FERR Lot IR0063 exp. 3/3/99, HCG Lot HP0177 exp.
6/25/00, MMB Lot FP0100 exp. 4/9/00, MMB Lot HN0178 exp. 6/26/00, MMB WA0190 exp. 7/8/00, MYO Lot FP0074 exp.
3/14/00, MYO Lot FN0074 exp. 3/14/00, PSA Lot WA0253 exp. 9/9/00, and PSA Lot HP0239
exp. 8/26/00.
REASON: Decline in stability following hydration.
MANUFACTURER: DADE BEHRING, INC., NEWARK,
DE
RECALLED BY: DADE BEHRING, INC., Deerfield, IL
DISTRIBUTION: Nationwide and Germany, Australia, Canada,
and Belgium.
QUANTITY: 6447 units