SEPTEMBER 2004
WEEK ENDING SEPTEMBER 4
PRODUCT
Shiley TracheoSoft® XLT Extended Length Tracheostomy tube, Model Numbers: 72110-050,
size 5;
Proximal Extension, Uncuffed, 72110-060, size 6;
Proximal Extension, Uncuffed; 72110-070, size 7;
Proximal Extension, Uncuffed; 72110-080, size 8;
Proximal Extension, Uncuffed; 72120-050, size 5;
Promixal Extension, Cuffed; 72120-060, size 6;
Promixal Extension, Cuffed; 72120-070, size 7;
Promixal Extension, Cuffed; 72120-080, size 8;
Promixal Extension, Cuffed; 73110-050, size 5;
Distal Extension, Uncuffed; 73110-060, size 6;
Distal Extension, Uncuffed; 72110-070, size 7;
Distal Extension, Uncuffed; 73110-080, size 8;
Distal Extension, Uncuffed; 73120-050, size 5;
Distal Extension, Cuffed; 73120-060, size 6;
Distal Extension, Cuffed; 73120-070, size 7;
Distal Extension, Cuffed; 73120-080, size 8;
Distal Extension, Cuffed; 77100-050, size 5;
XLT Disposal Inner Cannula; 77100-060, size 6;
XLT Disposal Inner Cannula; 77100-070, size 7;
XLT Disposal Inner Cannula; 77100-080, size 8.
CODE
All unit of above models.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett, Pleasanton, CA.
REASON
Device component can become disconnected or dislodged, leading to ineffective
ventilation, which could result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
71,021 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Sollux Systeme commercial tanning beds; Soleil Systems, Inc. The following models
are affected by this recall: a) Sollux Systeme 32 - 32 x 100 w tanning bulbs,
no facial tanner bulbs b) Sollux Systeme 32.3 - 32 x 100 w tanning bulbs, plus
3 x 400 w facial tanner bulbs c) Sollux Systeme 36 - 18 x 100 w reflective tanning
bulbs, 18 x 100 w tanning bulbs, no facial tanner bulbs d) Sollux Systeme 36.3
- 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, plus 3 x 400
w facial tanner bulbs e) Sollux System 40 - 20 x 160 w reflective tanning bulbs,
20 x 100 w reflective tanning bulbs, no facial tanner bulbs f) Sollux System
40.3 - 20 x 160 w reflective tanning bulbs, 20 x 100 w reflective tanning bulbs,
3 x 400 w facial tanner bulbs.
CODE
Each sunbed has two serial numbers, one on the canopy and another on the bench.
The serial numbers listed below list the canopy/bench.serial numbers followed
by the manufacturing date. a) Sollux Systeme 32 - 22 units, serial numbers 320002/320007
May 03; 320008/320014 May 03; 320010/320010 May 03; 320012/320012 May 03; 320015/321207
May 03; 320016/320016 May 03; 320017/320017 May 03; 320018/320018 May 03; 320019/320019
May 03; 320020/321202 May 03; 320021/321211 May 03; 320095/321264 Oct 03; 320096/321325
Oct 03; 320104/321284 Jun 03; 320106/321320 Jun 03; 320109/320109 May 03; 320111/321319
Aug 03; 320112/321314 Aug 03; 320123/321317 Sep 03; 320214/320214 May 03; 321211/321211
May 03; 321324/320113 Aug 03; b) Sollux Systeme 32.3 - 7 units, serial numbers
320007/321104 May 03; 320008/321109 May 03; 320009/321112 May 03; 320011/321316
Aug 03; 320093/321269 Oct 03; 320126/321268 Oct 03; 320127/321323 Oct 03; c)
Sollux Systeme 36 - 8 units, serial numbers 360004/360016 Sep 03; 360009/360015
May 03; 360012/361003 May 03; 360013/360021 Jun 03; 361001/360013 Aug 03; 361003/360017
Aug 03; 361041/361004 Oct 03; 361042/361001 Aug 03; d) Sollux Systeme 36.3 -
8 units, serial numbers 360011/360019 May 03; 360012/360015 May 03; 360013/360020
Jun 03; 360015/360010 May 03; 360016/360011 May 03; 360018/360014 My 03; 360020/360023
May 03; 360021/360027 May 03; e) Sollux System 40 - 1 unit, serial number 400002/400008
May 03; f) Sollux System 40.3 - 24 units, serial numbers 400002/400010 May 03;
400003/400021 Jul 03; 400004/400005 May 03; 400005/400020 Jun 03; 400006/400014
Jun 03; 400007/400004 Jun 03; 400008/400019 Aug 03; 400009/400094 Aug 03; 400010/400005
Jul 03; 400011/400023 Aug 03; 400012/400016 Apr 03; 400013/400017 Oct 03; 400116/400001
Sep 03; 400019/400020 Oct 03; 400021/400013 Aug 03; 400090/400015 Aug 03; 400095/400010
Aug 03; 400096/400021 Sep 03; 400097/400013 Oct 03; 400099/400018 Sep 03; 400102/400015
Sep 03; 400113/400012 Jul 03; 400114/400002 JUL 03; 400115/400009 Jul 03;
RECALLING FIRM/MANUFACTURER
Soleil Systems, Inc., Elk Grove Village, IL.
REASON
The sunlamp products failed to incorporate a timer system and a control for
termination of radiation emission in accordance with the Federal Sunlamp Product
Performance Standard.
VOLUME OF PRODUCT IN COMMERCE
70 beds.
DISTRIBUTION
MO, TX, VA, KY, and IL.
PRODUCT
a) Battery-operated Cautery Low Temperature, fine/elongated Tip.
b) Battery-operated Cautery High Temperature, fine/Loop/Vasectomy
CODE
a) Sterile lot numbers: 0204B 0204D 0204E 0304A 0304C 0304D 0404A
0404E 0404G 0404H 0404J 0504A 0504C 0504E 0504F. EXP DATES 2/1/08-
5/1/04;
b) Sterile lot numbers: 0104E 0204B 0204C 0204E 0304A 0304C 0404A
0404C 0404H 0404J 0404G 0504A 0504F 0204A 0304E 0504B 0204D 0504D
0504C 0504E 0504F. EXP DATES 2/1/08-5/1/04.
RECALLING FIRM/MANUFACTURER
Aaron Medical Industries, Inc., St. Petersburg, FL.
REASON
The cover caps on some of these cauteries are not properly engaged to prevent
inadvertent activation.
VOLUME OF PRODUCT IN COMMERCE
173,130 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) EasyDiagnost Eleva Part Number 9896 050 71921.
b) MultiDiagnost Eleva, Part Numbers: 9896 001 41501 and 9896 001
41502.
c) ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507
71831, and 9896 507 71832.
CODE
a) The firm uses site numbers instead of serial numbers. 103164,
105323, 505806, 500032, 105589, 105337, 506439, 505063, 505749,
505653, 505295, 105152, 505385, 505003, 506211, 504541, 505015,
504981, 504611, 104179, 505754, 505671, 505104, 103539, 102551,
505069, 102549, 504962, 104812, 504743, 105777, 103515, 103522,
103523, 103588, 504966, 504882, 505056, 504879, 105921, 505798,
105640, 105776, 506199, 504804, 504803;
b) 505039, 104530, 506247, 102666, 104136, 104838, 506155, 105194;
c) 83616, 103380, 102578, 105315, 504608, 104095, 104900, 103620,
505119, 105295, 103540, 105735, 105608, 105493, 101585, 225694,
102492, 504979, 102101, 105290, 105486, 505784, 104079, 504925,
504952, 505815, 505960.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA.
REASON
When reviewing images in the module before sending them to PACS or printer the
order can be erratic and out of sequence and may cause confusion with the interpretation
of the examination.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Merit MAK Mini Access Kit, 4 French (1.3mm). Catalog Number
MAK401.
b) Merit MAK Mini Access Kit, 4 French (1.3mm). Catalog Number
MAK401N.
c) Merit MAK Mini Access Kit, 4 French (1.3mm). Catalog Number
MAK405.
CODE
a) Lot Numbers: G322819, M9337627, MR314384, MR314386, MR317164,
MR320056.
b) Lot Numbers: G331723, G338460, M9337635, MR314388, MR317166,
MR320063;
c) Lot Numbers:G338462, M9337638, MR314387, MR317165, MR320060.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT.
REASON
Firm received a report of an introducer sheath separating from its hub while
in the patient. Surgery was successful in removal, even though the sheath kept
breaking during the attempt.
VOLUME OF PRODUCT IN COMMERCE
3,722 kits.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact
lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution
USP, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed
in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green
Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black
Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip,
Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire.
CODE
The majority of the vials in stock at the firm have lot number BB43 Expiration
Date 08/06.
RECALLING FIRM/MANUFACTURER
The Contact Lens Store, Inc., Marietta, GA.
REASON
The contact lenses were repacked in vials that were not sterile as indicated
on the vial labeling.
VOLUME OF PRODUCT IN COMMERCE
618 vials.
DISTRIBUTION
MA, TX, WA.
PRODUCT
Varian Mdical device and software systems. Version Numbers 6.2.27 and 6.2.35,
510k number K001643.
CODE
Serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315,
50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534,
51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045).
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA.
REASON
A malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which
is used to set up radiation therapy devices which will reset parameters to null
for future treatments if a patient receives treatment on a non-varian machine
and a varian machine and a non-varian field is loaded in the treatment session.
VOLUME OF PRODUCT IN COMMERCE
28 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single
unit packaged in a shelf carton. .
CODE
Lot Numbers--Exp.Date: M354580 -- 2004-03; M357300-- 2004-05; M401160-- 2004-08;
M401170 -- 2004-08; M413790 --2004-09; M414240 -- 2004-09; M437260 -- 2004-10.
RECALLING FIRM/MANUFACTURER
Datascope Interventional Products Division, Mahwah, NJ.
REASON
The motor may fail to activate when the on/off switch is pressed.
VOLUME OF PRODUCT IN COMMERCE
892 units.
DISTRIBUTION
Nationwide.
PRODUCT
Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA
Fortis Surgical Table Catalog No: MDTNA2.
CODE
131613, 131614, 131615, 131616,152144, 152145, 152147, 152148 219039, 219040,
219042, 219043, 232800, 232801, 232802, 232803, 232804, 205395, 205396, 235327,
235329, 235330, 237473, 237465, 237467, 237468, 237469, 237470, 237471.
RECALLING FIRM/MANUFACTURER
Allen Medical Systems, Acton, MA.
REASON
Neuro adapter may fail to engage and adequately clamp to the surgical table,
resulting in movement.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
SC.
Nellcor Puritan Bennett (Tyco Healthcare/Mallinckrodt) is conducting a nationwide recall of all of its CapnoProbes, a device similar to an electronic thermometer that is used by hospitals to measure the carbon dioxide in patients' tissues. Each probe is packaged in a metal canister filled with a saline solution and sealed in a foil envelope labeled as non-sterile. All of the CapnoProbes were manufactured at Nellcor's facility in Tijuana. Mexico. The probe and associated saline contain the bacteria Burkholderia Cepacia and other opportunistic pathogens that can cause serious infections, usually in persons who have decreased resistance to infection.
Nellcor notified its customers that they were recalling all lots of the CapnoProbe SLS-1 Sublingual Sensors and asked hospitals to return any unused inventory. The firm said the probe may pose a hazard to patients with compromised immune systems.
Physicians and patients can obtain further details about the recall from Nellcor at 1-800-635-5267, option 3.
WEEK ENDING SEPTEMBER 11
PRODUCT
Minerva Patient Lift, model ML-20; this lift has a passive lifting unit.
CODE
Model ML-20: serial numbers 952056, 952057, 952112, 952113, 952114, 952115,
952116, 952117, 962118, 952119, 952120, 952121, 962214, 962215, 962216, 962217,
962218, 962235, 962236, 962238, 962239, 962240, 962241, MPBX 97052M563, MPBX97052M564,
MPBX97052M565, MPBX97052M566, MPBX97052M567, MPBX97052M568, MPBX97052M569, MPBX97052M570,
MPBX97052M571, MPBX97052M572, MPBX97052M573, MPBX97052M574, MPBX97052M575, MPBX97052M576,
MPBX97052M577, MPBX97052M578, MPBX97052M579, MPBX98022M649, MPBX98022M650, MPBX98022M651,
MPBX98022M652, MPBX98022M653, MPBX98022M676, MPBX98022M677, MPBV00032M1013,
MPBV00072M1074.
RECALLING FIRM/MANUFACTURER
Medibo N.V., Hanmont, Achel, Belgium.
REASON
The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly
may come loose, and some units may have faulty actuator brackets on the mast
assembly, resulting in the patient lift becoming unstable and allowing the patient
to fall.
VOLUME OF PRODUCT IN COMMERCE
64 units.
DISTRIBUTION
CA, FL, LA, MA, NH, NJ, NY, OH, OR and PA.
PRODUCT
STS-T Mobile x-ray system used with the STS-T lithotripter. Model STS-T.
CODE
None provided.
RECALLING FIRM/MANUFACTURER
Medstone International, Inc., Aliso Viejo, CA.
REASON
Units are defective in that the identification and certification labels were
inadequate or missing. The beam limiting device was not appropriate for general
purpose radiographic procedures and the beam limiting device could ot collimate
down to 125 square centimeters or less as required.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide.
PRODUCT
iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing
wheelchair), Class III restricted medical device. The device is shipped one
each per wooden pallet with wooden sides and top retained by reusable bands.
CODE
Catalog No.ís IT000101-IT000148 (inclusive), Vehicle Identification Numbers (ëVINís): 020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331,
020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341,
021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348,
020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319,
021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349,
021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345,
020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355,
020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343,
020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367,
020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316,
020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312,
020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297,
021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287,
021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277,
021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281,
021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288,
021103-000284, 021203-000302.
RECALLING FIRM/MANUFACTURER
Independence Technology LLC, Warren, NJ.
REASON
IBOT Mobility System may tip over due to malfunction in power base.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
Nationwide, UK, Ireland, and New Zealand.
PRODUCT
The Model 8540 Catheter Access Port Kit is intended for use in accessing the
catheter via the catheter access port of Medtronic(R) implantable programmable
infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access
Port Kit does not have a product code for itself; it is approved under PMA P860004.
PMA P860004 is classified as: pump, infusion, implanted, programmable under
product code LKK.
CODE
CS0293.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN.
REASON
The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly
labeled with a Model 8551 Refill kit label. The outer box of the affected Model
8540 Catheter Access Port kit is labeled correctly and the component parts within
the sterile tray are the correct components for a Model 8540 Catheter Access
Port kit. The issue is limited to one lot of product: CS0293.
VOLUME OF PRODUCT IN COMMERCE
405 kits.
DISTRIBUTION
Nationwide and New Zealand.
PRODUCT
a) Weck Hemoclip Traditional Ligating Clips, Ref No. 523170 Hemoclip, 15 Large Tantalum Clips/Cartridge and Ref. No.
523370 Hemoclip 10 Large Tantalum Clips/Cartridge.
b) Weck Atrauclip Ligating Clips, Ref. No. 121505 Atrauclip, 15 Large Titanium Clips/Cartridge and Ref.
No. 121506 Atrauclip, 10 Large Titanium Clips/Cartridge.
c) Weck Hemoclip Traditional Ligating Clips, Ref. No.
523770 Hemoclip, 15 Large Titanium Clips/Cartridge, and
Ref. No. 523870 Hemoclip 10 Large Titanium
Clips/Cartridge.
d) Weck Hemoclip Traditional Ligating Clips, Ref. No.
523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-
Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum
Clips/Cartridge (Non-Sterile).
e) Weck Hemoclip Traditional Ligating Clips, Ref. No.
523771 - Hemoclip, 15 Large Titanium Clips/Cartridge
(Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large
Titanium Clips/Cartridge (Non-Steile).
f) Weck Hemoclip Traditional Ligating Clips, Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and
Ref. No. 523670 Hemoclip, 10 Large Stainless Steel
Clips/Cartridge.
g) Weck Hemoclip Plus Ligating Clips, Ref. No. 533702
Hemoclip Plus, 25 Medium Titanium Clips, No Tape; Ref.
No. 533737 Hemoclip Plus, 25 Small Titanium
Clips/Cartridge, No Tape and Ref. No. 533872 Hemoclip
Plus, 10 Large Titanium Clips/Cartridge, No Tape.
h) Weck Hemoclip Plus Ligating Clips, Ref. No. 533735 and
534735 Hemoclip Plus, 25 Small Titanium Clips,
Cartridge; Ref. No. 533870 Hemoclip Plus, 10 Large
Titanium Clips/Cartridge and Ref. No. 533700 Hemoclip
Plus, 25 Medium Titanium Clips/Cartridge.
CODE
a) All lots manufactured between 2001-8 through 2002-12 for
the 15 and 10 Large Tantalum Clips and additional Lots
763010, 763011, 769345 and 831864 for the 10 Large
Tantalum Clips;
b) All lots manufactured between 2001-8 through 2002-12;
c) All lots manufactured between 2001-8 through 2002-12 for
the 15 and 10 Large Titanium Clips and additional lots
799983, 816529, 826816, and 840190 for the 10 Large
Titanium Clips;
d) All lots manufactured between 2001-8 through 2002-12 for
the 10 and 15 Large Tantalum Clips and lot 763013 for
the 15 Large Tantalum Clips;
e) All lots manufactured between 2001-8 throught 2002-12
for the 15 and 10 Large Titanium Clips and lots 880608
and 944135 for the 10 Large Titanium Clips;
f) All lots manufactured between 2001-8 thorugh 2002-12 for
15 Large and 10 Large Stainless Steel Clips and lot
809026 for the 10 Large Stainless Steel Clips;
g) All lots manufactured between 2001-8 thorugh 2002-12 for
all three products and lot 763100 for 25 Medium Titanium
Clips, lots 763102 and 949861 for 25 Small Clips and lot
814007 for 10 Large Titanium Clips;
h) All lots manufactured between 2001-8 through 2002-12 for
all three products and lots 738967, 763871 and 714124
for 25 Small Titanium Clips; lots 703251, 722666 and
825952 for 10 Large Titanium Clips and lots 738966,
754641 and 824238 for 25 Medium Titanium Clips.
RECALLING FIRM/MANUFACTURER Weck, NC.
REASON
Hole in the sterile unit blister pack that could compromise sterility.
VOLUME OF PRODUCT IN COMMERCE
91,869 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) SMV FX-40 Nuclear Camera.
b) SMV FX-80 Nuclear Camera.
CODE
a) 00000000000194, 00000000000222, 0070090040-100,
0070090040-101, 0070090040-105, 0070090040-111, 0070090040-113, 0070090040-114,
0070090040-117, 0070090040-120, 0070090040-122, 0070090040-128, 0070090040-129,
0070090040-131, 0070090040-132, 0070090040-133, 0070090040-134, 0070090040-136,
0070090040-137, 0070090040-139, 0070090040-144, 0070090040-147, 0070090040-148,
0070090040-149, 0070090040-151, 0070090040-154, 0070090040-156, 0070090040-157,
0070090040-159, 0070090040-160, 0070090040-166, 0070090040-171, 0070090040-175,
0070090040-177, 0070090040-182, 0070090040-183, 0070090040-185, 0070090040-189,
0070090040-190, 0070090040-192, 0070090040-193, 0070090040-195, 0070090040-196,
0070090040-197, 0070090040-198, 0070090040-199, 0070090040-200, 0070090040-201,
0070090040-202, 0070090040-204, 0070090040-205, 0070090040-206, 0070090040-207,
0070090040-208, 0070090040-210, 0070090040-211, 0070090040-212, 0070090040-213,
0070090040-215, 0070090040-216, 0070090040-217, 0070090040-219, 0070090040-221,
0070090040-222, 0070090040-939;
b) 00000000000172, 00000000000173, 00000000000188,
00000000000203, 00000000000209, 00000000000214,
00000000000223, 0070090080-103, 0070090080-106,
0070090080-107, 0070090080-112, 0070090080-115,
0070090080-116, 0070090080-123, 0070090080-124,
0070090080-125, 0070090080-126, 0070090080-127,
0070090080-138, 0070090080-141, 0070090080-146,
0070090080-150, 0070090080-152, 0070090080-158,
0070090080-161, 0070090080-162, 0070090080-163,
0070090080-164, 0070090080-165, 0070090080-167,
0070090080-168, 0070090080-170, 0070090080-172,
0070090080-173, 0070090080-179, 0070090080-180,
0070090080-188, 0070090080-203, 0070090080-209,
0070090080-96, 0070090080-P298.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI.
REASON
The detector head of a FX-80 Nuclear camera may fall from the gantry. Three
potential causes have been determined. (1) A ball nut in the detector's radial
drive assembly can back out of the bearing block that contains it. (2) Misalignment
of the radial drive assembly. (3) Mounting bolts on the radial drive assembly
may become loose, fail, or back out.
VOLUME OF PRODUCT IN COMMERCE
96 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Magnetom Avanto MRI System, Model 7391167.
b) Magnetom Harmony MRI System Model number 7106714.
c) Magnetom Harmony MRI System Model number 5751438,
d) Magnetom Symphony MRI System, Model 7106557.
e) Magnetom Symphony MRI System, Model 7104594.
f) Magnetom Sonata MRI System, Model 7388148.
g) Magnetom Sonata MRI System, Model 7104719.
h) Magnetom Sonata MRI System, Model 7106425.
i) Magnetom Trio MRI System, Model 7106441.
j) Magnetom Trio MRI System, Model 7387074.
CODE
a) Serial numbers 25001 ‚ 25129;
b) Serial number 10502;
c) Serial number 15002;
d) Serial numbers 14018 and 14108;
e) Serial numbers 22009, 22016, and 22081;
f) Serial numbers 16502 and 16509;
g) Serial numbers 21151 and 21223;
h) Serial numbers 21921;
i) Serial numbers 20500, 20502, and 20507;
j) Serial numbers 20554, 20561, and 20569.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern PA.
REASON
An input error can be made with Magnetom MRI software. Software allows users
to manually change Transmit Reference Voltage in certain windows.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
Nationwide.
PRODUCT
Guardian’ Distal Femur Axial Pin.
CODE
Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391
Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533
Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074.
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc, Arlington, TN.
REASON
Potential for self-locking axial pin to dislodge and ìback outî.
VOLUME OF PRODUCT IN COMMERCE
44 units.
DISTRIBUTION
Nationwide, Ontario, and Taiwan, ROC.
PRODUCT
a) Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone
wound drain; a sterile, single use only, Rx device,
individually packaged, 10 drains per box, 8 boxes per
case; catalog #JP-HUR880; catalog #JP-HUR880,
b) Jackson-Pratt Reservoir, 400 mL suction reservoir;
a sterile, single use only, Rx device used as a
component of the wound drain system, individually
packaged, 10 reservoirs per case, catalog #SU130-1000;
CODE
a) Lot 1040909;
b) Lots 1040877, 1040879, 1040991, and 1040992.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL.
REASON
The products labeled as sterile are not sterile.
VOLUME OF PRODUCT IN COMMERCE
170 cases.
DISTRIBUTION
FL, AZ, NJ, and Canada.
PRODUCT
a) Peritoneal Lavage Kits, Model number AK-09000.
b) Peritoneal Lavage Kits, Model number AK-09001.
CODE
a) Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06,
RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp.
8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06,
RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592
exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp.
12/06;
b) Lot numbers: RF3111152 exp. 5/08, RF3121739 exp. 8/06,
RF4012282 exp. 7/08, RF4012530 exp. 7/08, RF4034376 exp.
10/06, RF4034554 exp. 11/08, RF4045029 exp. 11/08, and
RF4066325 exp. 1/09.
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA.
REASON
Wrong introducer needle in some kits.
VOLUME OF PRODUCT IN COMMERCE
8,090 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Esophageal Z-StentÆ Fully Coated or Uncoated Flanges, Endoprosthesis Systems
with the Z Speed Introducer, Disposable - Single Use Only, Rx Only, Sterile EO, Order Number EZSP-25-10-FC.
CODE
Lot Number R1688574.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston-Salem, NC.
REASON
Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CT, HI, LA, MO, and PA.
PRODUCT
Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No.
905414 and Biomet Ref. No. 450026.
CODE
Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN.
REASON
The cautery cover cap may become dislodged during shipping or handling, the
cautery switch may be activated and the cautery may melt or burn through the
packaging pouch.
VOLUME OF PRODUCT IN COMMERCE
130 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) ConMed Stealth Coated Laparoscopic Electrodes with
3/32î pin (60-5158 series) as follows: Cat. #60-5158-027
Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm
x 32 cm; Cat. #60-5158-044 - Spatula 5 mm x 44 cm; Cat
#60-5158-127 - L Hook 5 mm x 27 cm; Cat #60-5158-132 - L Hook, 5 mm x 32 cm;
Cat #60-5158-144 - L Hook 5 mm x 44 cm; Cat #60-5158-232 - J Hook 5mm x 32 cm;
Cat. #60-5158-244 - J Hook 5mm x 44 cm; Cat #60-5158-927 - Needle 5 mm x 27
cm; Cat #60-5158-932 - Needle 5 mm x 32 cm;
b) ConMed Stealth Coated Laparoscopic Electrodes with 4mm
pin (60-5158 series) as follows: Cat. #60-5158-034 ‚
Spatula, 5 mm x 32 cm; Cat #60-5158-432 ‚ ìLî Hook 5 mm
x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm.
CODE
a) Lot #s 0309121, 0310301, 0401051, 0404271, 0405031;
Lot #s 0309011, 0309111, 0401121, 0402031, 0402271, 0404131, 0405031, 0406071;
Lot #s 0309151, 0403121;
Lot #s 0309021, 0309151, 0310301;
Lot #s 0308071, 0308211, 0310081, 0311031, 0311101, 0401051, 0402031, 0402271,
0403121, 0404131;
Lot #s 0308261, 0310061, 0310081, 0311101, 0402031, 0403031, 0403121, 0406071;
Lot #s 0309121, 0310301, 0402181, 0404301;
Lot #s 0309121, 0310081, 0402271, 0404301;
Lot # 0309021;
Lot #0308111, 0309021, 0310081, 0311101, 0401121, 0402181, 0403121;
b) Lot #s 0309121; Lot #s 0308071, 0309021, 0309151, 1121;
Lot #s 0309111.
RECALLING FIRM/MANUFACTURER
ConMed Corporation, Utica, NY.
REASON
Insulation may pull away from the hub of the electrode exposing the conductive
shaft below. This condition results in potential for electrical shock.
VOLUME OF PRODUCT IN COMMERCE
6,472 units.
DISTRIBUTION
Nationwide and Internationally.
WEEK ENDING SEPTEMBER 18
PRODUCT
The probes involved have been part of the NellcorÆ CapnoProbeTM SLS~1 Sublingual
System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1
Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled
with a nonsterile buffered saline solution. The canister is in a sealed foil
envelope. Each disposable probe is used only one time.
CODE
All lots of the CapnoProbe are under recall. Each unit has a code number printed
on the packaging.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett, Pleasanton, CA.
REASON
The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas
cepacia), based on the Texas Health Department analysis and also firm's analysis.
VOLUME OF PRODUCT IN COMMERCE
14,120 units.
DISTRIBUTION
Nationwide and Europe.
PRODUCT
ProlieveΠThermodilatation System, Model
number
M0068808000.
CODE
CEL0204AK, CEL0204BK, CEL0204CK, CEL0204DK, CEL0204EK, CEL0204FK, CEL0204GK,
CEL0204HK, CEL0204IK, CEL0204JK, CEL0604AK, CEL0604BK, CEL0604CK, CEL0604DK,
CEL0604EK, CEL0604FK, CEL0604GK, CEL0604HK, CEL0604IK, CEL0604JK, CEL0604KK,
CEL0604LK, CEL0604MK, CEL0604NK, CEL0604OK, CEL0604PK, CEL1904AK, CEL9404BK.
RECALLING FIRM/MANUFACTURER
Celsion Corporation, Columbia, MD.
REASON
Software controlling a medical device for patient treatment may malfunction
and cause thermal injury to patient.
VOLUME OF PRODUCT IN COMMERCE
28 devices.
DISTRIBUTION
Nationwide.
PRODUCT
Harmony MIS Life Instruments, Lumbar Spacer Systems. Part numbers 2851-1-01,
2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30,
2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2858-1,
2859-1, 2861-5, and 2862-1.
CODE
Lot number 18YH, 18YJ, 18YK, 18YL, 18YM, 18YP, 18YQ, 18YR, 18YS, 18YT, 18YW,
18YX, 18YZ, 18YY, 18ZA, 18ZB, 18ZC and 18ZD.
RECALLING FIRM/MANUFACTURER
Spinal Concepts, Inc., Austin, TX.
REASON
Handle becomes loose after repeated use.
VOLUME OF PRODUCT IN COMMERCE
646 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 17 Fr, guidewire stylet, ribbed balloon; catalog
number 4427.
b) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 17 Fr, steerable stylet, ribbed balloon; catalog
number 4428.
c) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 17 Fr, malleable stylet, ribbed balloon; catalog
number 4429.
d) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 17 Fr, malleable stylet, ribbed balloon; catalog
number 4430.
e) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 13 Fr, steerable stylet, ribbed balloon; catalog
number 5578.
f) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 13 Fr, malleable stylet, ribbed balloon; catalog
number 5579.
g) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog
number 5580.
h) Sarns brand Retrograde Cardioplegia Cannulae, auto‚
inflate, 13 Fr, malleable stylet, ribbed balloon, extended
length, 14" (35 cm) long; catalog number 5584.
i) Sarns brand Retrograde Cardioplegia Cannulae, auto‚
inflate, 13 Fr, steerable stylet, ribbed balloon, extended
length, 14" (35 cm) long; catalog number 5585.
j) Sarns brand Retrograde Cardioplegia Cannulae, auto‚
inflate, 13 Fr, rigid stylet, ribbed balloon, standard
length, 12" (30.5 cm) long; catalog number 5586.
k) Sarns brand Retrograde Cardioplegia Cannulae, auto‚
inflate, 13 Fr, rigid stylet, ribbed balloon, extended
length, 14" (35 cm) long; catalog number 5587.
l) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 15 Fr, guidewire stylet, smooth balloon; catalog
number 7270.
m) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 15 Fr, steerable stylet, smooth balloon; catalog
number 7271.
n) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 15 Fr, guidewire stylet, ribbed balloon; catalog
number 7272.
o) Sarns brand Retrograde Cardioplegia Cannulae, manual‚
inflate, 15 Fr, steerable stylet, ribbed balloon; catalog
number 7273.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI.
REASON
The product is labeled as sterile, but sterility is compromised because some
of the packages were not sealed.
VOLUME OF PRODUCT IN COMMERCE 40,895 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor CT/NG CT Detection Kit.
b) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor CT/NG NG Detection Kit.
c) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0.
d) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor HCV Detection Kit, 96 test.
e) Amplicor (3) AV-HRP. Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: AmpliCap HCV Monitor Test, Export, RUO.
f) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor IC Detection Kit, Export, IVD/CE.
g) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor M. avium Detection Kit, Export, RUO.
h) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor MTB Detection Kit, Gen 2 Export, IVD/CE.
i) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor NG Detection Kit, Export, IVD/CE.
CODE
a) Lot No. E09569 found in kit lot: Lot No. E12231, Material No.
2075932018, Exp. 2/2005;
b) Lot No. E09560 found in kit lot: Lot No. E12647, Material No.
20759406018, Exp. 2/2005;
c) Lot No. E09569 found in kit lot: Lot No. F01023, Material No.
21118439018, Exp. 5/2005;
d) Lot No. E09569 found in kit lot: Lot No. E09554, Material No.
2075952018, Exp. 5/2005;
e) Lot No. E09569 found in kit lot: Lot No. E09193, Material No.
21111337018, Exp. 8/2004;
f) Lot No. E09569 found in kit lot: Lot No. E13115, Material No.
20763306122, Exp. 7/2005;
g) Lot No. E09569 found in kit lot: Lot No. E12990, Material No.
20759880018, Exp. 11/2004;
h) Lot No. E09569 found in kit lot: Lot No. E13307, Material No.
20757462122, Exp. 9/2004;
i) Lot No. E09569 found in kit lot: Lot No. E10894, Material No.
20744026122, Exp. 2/2005.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ.
REASON
An increased frequency of "blue foci" that potentially can cause elevated
A450 background in microwell plate wells after the addition of conjugate reagent
during PCR detection.
VOLUME OF PRODUCT IN COMMERCE
11,842 kits.
DISTRIBUTION
Nationwide, Germany, Canada and Japan.
PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
CODE
All units using software version 3.03.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN.
REASON
A hardware/software problem will result in low elution volumes and bias sample
results for various protocols.
VOLUME OF PRODUCT IN COMMERCE
192.
DISTRIBUTION
Nationwide.
PRODUCT
Abbott Clinical Chemistry AEROSET/ARCHITECT c8000 Creatinine. List No. 7D64-20.
CODE
Lot 14032HW00 Exp: November 17, 2005 and lot 17054HW00 Exp: November 17, 2005.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA.
REASON
Precipitate formed in product.
VOLUME OF PRODUCT IN COMMERCE
3,800.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
SYNCHRON Clinical Systems Enzyme Validator Kit.
CODE
M310400.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA.
REASON
Incorrect Calibration Acceptance Limits.
VOLUME OF PRODUCT IN COMMERCE
771 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Otto Bock 3R90 and 3R92 Modular Knee Joint with Friction Brake.
CODE
No lot numbers are used. Recall covers patients who were fit with either of
the products between March 1, 2004 and July 9, 2004.
RECALLING FIRM/MANUFACTURER
Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN.
REASON
Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may
become dislodged which may cause the breaking performance of the knee to malfunction.
VOLUME OF PRODUCT IN COMMERCE
437 devices.
DISTRIBUTION
Nationwide.
PRODUCT
Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part number:
8900-2065.
CODE
Lot numbers: 3103, 3203, 3303, 3403, 3503, 3603, 3703, 3803, 3903, 4003, 4103,
4203, 4303.
RECALLING FIRM/MANUFACTURER Bio-Detek, Inc., Pawtucket, RI.
REASON
Pads may fail due to excessive corrosion of the electrode prior to the expiration
date.
VOLUME OF PRODUCT IN COMMERCE
9,971 pairs.
DISTRIBUTION
Nationwide.
PRODUCT
a) ADP2.1 Adapter, non-sterile reusable Model Number:
30-802-1, an accessory used with the TissueLink BiPolar
Floating Device.
b) ADP 3.2 Adapter, non sterile reusable Model Number:
30-801-1, an accessory used with the TissueLink Bipolar
Floating Device.
CODE
a) Lot Numbers: TLK113A0, TLL113A0, TLL29300, TLL293A0,
TLL293B0, TLC18400;
b) Lot Numbers: TLK17300, TLB02400.
RECALLING FIRM/MANUFACTURER
TissueLink Medical, Inc., Dover, NH.
REASON
Adapter when connected to a generator may short circuit resulting in lack of
power and/or thermal warming of the ADP housing.
VOLUME OF PRODUCT IN COMMERCE
164 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Allegiance Laminated Wood Crutches, item 74151-010,
Large Adult ‚ 51" ‚ 64"; 1 pair individually shrink
wrapped, 10 pairs per case; catalog #74151-010, all
product labeled Made in China.
b) Allegiance Laminated Wood Crutches, item 74151-020,
Adult ‚ 47" ‚ 57"; 1 pair individually shrink wrapped,
10 pairs per case; catalog #74151-020, all PRODUCT
labeled, Made in China.
c) Allegiance Laminated Wood Crutches, item 74151-030,
Medium ‚ 43" ‚ 53"; 1 pair individually shrink wrapped,
10 pairs per case; catalog #74151-030, all PRODUCT
labeled Made in China.
d) Allegiance Laminated Wood Crutches, item 74151-040,
Youth ‚ 35" ‚ 43"; 1 pair individually shrink wrapped,
10 pairs per case; Made in China, catalog #74151-040.
e) Allegiance Laminated Wood Crutches, item 74151-050,
Child ‚ 28" ‚ 36"; 1 pair individually shrink wrapped,
10 pairs per case; Made in China, catalog #74151-050.
CODE
All product labeled Made in China.
RECALLING FIRM/MANUFACTURER Duro-Med Industries, Inc., Jessup, GA.
REASON
The crutches were labeled as latex free, but contain rubber in the hand grips,
tips and underarm padding of the crutches.
VOLUME OF PRODUCT IN COMMERCE
4,768 cases.
DISTRIBUTION
Nationwide.
PRODUCT
a) Telesheath Left Atrial Introducer System Right Superior.
Telesheath Catheter Two-Piece Introducer Kit with
Hemostasis Valve. Right Superior Reorder #407900. The
product is packaged in an open, semi-rigid plastic tray,
which is then placed in a sterile barrier pouch
consisting of Tyvek on one side and a clear plastic film
on the other. This pouch is then heat sealed prior to
sterilization.
b) Telesheath Left Atrial Introducer System Right Superior.
Telesheath Catheter Two-Piece Introducer Kit with
Hemostasis Valve. Left Lateral Reorder #407901. The
product is packaged in an open, semi-rigid plastic tray,
which is then placed in a sterile barrier pouch
consisting of Tyvek on one side and a clear plastic film
on the other. This pouch is then heat sealed prior to
sterilization.
CODE
a) 1063073 - Exp. Date: 03/2007, 1075105, - Exp. Date:
05/2007 1077015 - Exp. Date: 06/2007, 1079062 - Exp
Date: 06/2007;
b) 1063074 - Exp Date: 03/2007, 1075104, - Exp. Date:
05/2007, 1076753 - Exp. Date: 06/2007.
RECALLING FIRM/MANUFACTURER
St. Jude Medical/Daig Division, Minnetonka, MN.
REASON
St. Jude Medical received two complaints from customers involving the Telesheath
Left Atrial Introducer System side arm detaching from the hub of the inner sheath.
Subsequent testing of Telesheath inventory at St. Jude Medical indicated that
the side arm from the inner sheath can detach during routine handling and manipulation,
and occurs on a random basis.
VOLUME OF PRODUCT IN COMMERCE
347 kits.
DISTRIBUTION
US, Canada, Belgium, Hong Kong, and Japan.
PRODUCT
a) Roche/Hitachi 747 - 100 clinical chemistry analyzer;
catalog number 04009223680.
b) Roche/Hitachi Modular Analytical D Module clinical
chemistry analyzer; catalog number 03739023001.
c) Roche/Hitachi Modular Analytical D Module DAT clinical
chemistry analyzer; catalog number 04429338160.
d) Roche/Hitachi Modular Additional D Module DAT clinical
chemistry analyzer; catalog number 04429389160.
e) Roche/Hitachi 747 - 200 clinical chemistry analyzer;
catalog number 04009223680.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN.
REASON
A software defect will allow the reporting out of believable, but clinically
significant, erroneous results if the analyzer is in operation and a channel
has been masked or not requested over a period of time.
VOLUME OF PRODUCT IN COMMERCE
392 units.
DISTRIBUTION
Nationwide.
PRODUCT
COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834
software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated
hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic
Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated
reticulocyte analysis.
CODE
Software versions 1A and 1A2.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA.
REASON
Beckman Coulter has confirmed an issue associated with the predilute mode of
the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit,
and/or print an erroneous result or an incorrect dilution factor with a predilute
sample result.
VOLUME OF PRODUCT IN COMMERCE
222 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
AxSYM Total B-hCG Reagent Pack.
CODE
Lot numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date
10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR.
REASON
For failing calibrations.
VOLUME OF PRODUCT IN COMMERCE
3,220 kits.
DISTRIBUTION
NY, WI, CA, SC, FL, MO, and Internationally.
PRODUCT
Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part #
D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S
107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.
CODE
112 lots.
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc, Irwindale, CA.
REASON
Potential that product is incorrectly assembled with monel wire attached to
the tip dome rather than copper wire.
VOLUME OF PRODUCT IN COMMERCE
848.
DISTRIBUTION
Nationwide and Japan, Europe, and Uruguay.
PRODUCT
Optima Spinal System and Spinal Hook System, set screw component. Part number
SP3020 (revision 6).
CODE
Lot # 04D033.
RECALLING FIRM/MANUFACTURER
U&I America, Murray, UT.
REASON
Threads on a set screw, as a component of a spinal fixation system, may break
off during use.
VOLUME OF PRODUCT IN COMMERCE
60 screws.
DISTRIBUTION
CA.
PRODUCT
a) Sheep Blood, Defibrinated ‚ Catalog Number 211946, Unit 100
ml.
b) Sheep Blood, Defibrinated ‚ Catalog Number 212391, Unit 250
c) Sheep Blood, Defibrinated ‚ Catalog Number 212389, Unit 30
d) Sheep Blood, Defibrinated ‚ Catalog Number 211947, Unit 500
e) Sheep Blood, Defibrinated ‚ Catalog Number 211945, Unit 15
f) Sheep Blood, Defibrinated ‚ Catalog Number 212390, Unit 100
ml.
g) BBL Brain Heart Infusion Agar w/10% Sheep Blood ‚ Catalog
Number 297655.
h) BBL TSA II w/5% Sheep Blood, Spacesaver ‚ Catalog Number
292537.
i) BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB ‚
Catalog Number 295618.
j) BBL Brain Heart Infusion Agar CC w/ Sheep Blood ‚ Catalog
Number 296178.
k) BBL Columbia C.N.A. Agar w/5% Sheep Blood, ‚ Catalog Number
297831.
CODE
a) Lot number: 4155326 and Expiration date: June 29, 2004;
b) Lot number: 4155341 and Expiration date: June 29, 2004;
c) Lot number: 4155337 and Expiration date: June 29, 2004;
d) Lot number: 4155332 and Expiration date: June 29, 2004;
e) Lot number: 4155324 and Expiration date: June 29, 2004;
f) Lot number: 4155328 and Expiration date: June 29, 2004;
g) Lot number: 4146359 and Expiration date: August 02, 2004;
h) Lot number: 4153582 and Expiration date: September 09, 2004;
i) Lot number: 4153593 and Expiration date: August 26, 2004;
j) Lot number: 4153588 and Expiration date: September 23, 2004;
k) Lot number: 4154491 and Expiration date: August 19, 2004.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD.
REASON
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
VOLUME OF PRODUCT IN COMMERCE
9510.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) P.F.C. ® -- Knee System 7ƒ Fluted Femoral Stem 18mmX125mm
REF 96-1703.
b) P.F.C. ® -- Knee System 7ƒ Fluted Femoral Stem 18mmX130mm
REF: 96-1731.
CODE
a) Lot Number: 226436R;
b) Lot Number: 226287R.
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN.
REASON
The collar was incorrectly etched for the R (Right) and L (Left) orientation.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
PRODUCT
ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
CODE
Lot #910718.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON
A potential contamination was noted in the conjugate in ProSpecT Campylobacter
Microplate Assay. The particulate in the conjugate may cause the dropper tip
to become plugged.
VOLUME OF PRODUCT IN COMMERCE
382.
DISTRIBUTION
Germany.
PRODUCT
ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay. Catalog # 2474048 (48
well plate) and 2474096 (96 well plate). For qualitative detection of Shiga
toxins (STX1 & STX2) in aqueous extracts of fecal specimens and fecal enriched
broth cultures.
CODE
918706 918707.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON
A potential contamination was noted and the particulate in the conjugate may
cause the dropper tip to become plugged.
VOLUME OF PRODUCT IN COMMERCE
83.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
ProSpecT Giardia Cryptosporidium Microplate Assay. Catalog # 2458496. .
CODE
926230.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON
The conjugate may have become contaminated during filing. The particulates in
the contamination may cause the dropper tips to become plugged.
VOLUME OF PRODUCT IN COMMERCE
12.
DISTRIBUTION
Nationwide.
PRODUCT
ProSpecT Giardia Cryptosporidium Microplate Assay. Catalog # 2458496.
CODE
944755.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON
The conjugate may cause the negative control to produce high OD readings, therefore
invalidating the run.
VOLUME OF PRODUCT IN COMMERCE
127.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
ProSpecT Cryptosporidium Microplate Assay. Catalog # 2454096. .
CODE
910717 912101.
RECALLING FIRM/MANUFACTURER Remel, Inc, Lenexa, KS.
REASON
The Positive Control may NOT perform as intended through its expiration date
and may invalidate an otherwise acceptable run.
VOLUME OF PRODUCT IN COMMERCE
388.
DISTRIBUTION
Nationwide.
PRODUCT
P.F.C.Æ Modular Knee System Modular Plus Tibial Wedge 10ƒ HEMI x 8.5MM HEIGHT
Product Code: 86-0178.
CODE
Lot Umber: 330722.
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN.
REASON
Screw size included in system was incorrect.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IA.
PRODUCT
a) Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the
Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number
1877470 (11877470216).
b) Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the
Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number
1928511 (11928511216).
CODE
a) All lots expiring on or before 11/05;
b) All lots expiring on or before 7/05.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN.
REASON
Rotation of the instrument reagent compartment can cause a bubble to form in
the neck of the reagent bottle causing premature liquid level detection and
short sampling of the reagent, resulting in falsely low or zero patient results.
VOLUME OF PRODUCT IN COMMERCE
1,485.
DISTRIBUTION
Nationwide.
PRODUCT
Amigo Insulin Infusion Pump. Model #s 990001, 990002, 990003, 990004,
990005, and 990006.
CODE All associated codes.
RECALLING FIRM/MANUFACTURER
Nipro Diabetes Systems, Inc, Miramar, FL.
REASON
A FDA inspection of the firm revealed deficiencies in the company’s
quality system. Problems exhibited may include motor failure or
unintended operation.
VOLUME OF PRODUCT IN COMMERCE
8.
DISTRIBUTION
NY, NJ, FL, IN, UT, CO, and WY.
PRODUCT
a) Standard and Custom Spinal Trays with 5% Lidocaine
Hydrochloride 2 ml ampul.
b) Standard and Custom Spinal Trays with 7.5% Dextrose Injection
USP 2 ml ampul.
CODE
a) Catalog number 333027 Lot number 60544516,
Catalog number 333200 Lot number 60536446,
Catalog number 333210 Lot numbers 60536450 and 60542855,
Catalog number 333230 Lot number 60542857,
Catalog number 333742 Lot numbers 60536470, 60544549, and
60544550, Catalog number 333752 Lot number 60544557,
Catalog number 333852 Lot numbers 60536493 and 60544563,
Catalog number 333861 Lot numbers 60517577 and 60517578,
Catalog number 333872 Lot number 60544582,
Catalog number 560074 Lot number 60537371,
Catalog number 560123 Lot number 60549408,
Catalog number 560130 Lot number 60549409,
Catalog number 560156 Lot number 60547692,
Catalog number 560176 Lot number 60537460,
Catalog number 560214 Lot number 60563428,
Catalog number 560269 Lot number 60540604,
Catalog number 560327 Lot numbers 60537472 and 60549429,
Catalog number 560386 Lot number 60549439,
Catalog number 560397 Lot number 60527954,
Catalog number 560399 Lot number 60540619,
Catalog number 560408 Lot number 60537475,
Catalog number 560436 Lot number 60549863,
Catalog number 560485 Lot number 60540907, and
Catalog number 560505 Lot number 60566553;
b) Catalog number 333027 Lot number 60544516,
Catalog number 333200 Lot number 60536446,
Catalog number 333210 Lot numbers 60536450 and 60542855,
Catalog number 333230 Lot number 60542857,
Catalog number 333742 Lot numbers 60536470, 60544549, and
60544550,
Catalog number 333752 Lot number 60544557,
Catalog number 333852 Lot numbers 60536493 and 60544563,
Catalog number 333861 Lot numbers 60517577 and 60517578,
Catalog number 333872 Lot number 60544582,
Catalog number 560074 Lot number 60537371,
Catalog number 560123 Lot number 60549408,
Catalog number 560130 Lot number 60549409,
Catalog number 560156 Lot number 60547692,
Catalog number 560176 Lot number 60537460,
Catalog number 560214 Lot number 60563428,
Catalog number 560269 Lot number 60540604,
Catalog number 560327 Lot numbers 60537472 and 60549429,
Catalog number 560386 Lot number 60549439,
Catalog number 560397 Lot number 60527954,
Catalog number 560399 Lot number 60540619,
Catalog number 560408 Lot number 60537475,
Catalog number 560436 Lot number 60549863,
Catalog number 560485 Lot number 60540907, and
Catalog number 560505 Lot number 60566553.
RECALLING FIRM/MANUFACTURER
B. Braun Medical, Inc., Allentown, PA.
REASON
Drug ampuls in kits contain particulates.
VOLUME OF PRODUCT IN COMMERCE
2,261 cases.
DISTRIBUTION
FL, NC, NY, OH, and PA.
PRODUCT
Anestar Anesthesia Delivery System.
CODE
Serial#: 4600010001; 4600010003; 4600010004; 4600010007; 4600010008;
4600010009; 4600010010; 4600010012; 4600A20017; 4600A20018; 4600A20019;
4600A20020; 4600A20021; 4600A20023; 4600A20024; 4600A30066; 4600A30067;
4600A30068; 4600A30069; 4600A30070; 4600A30071; 4600A30072; 4600A30073;
4600A30074; 4600A30075; 4600B10002; 4600B20025; 4600B20026; 4600B20027;
4600B20028; 4600B20029; 4600B20030; 4600B20031; 4600B20032; 4600B20033;
4600B20034; 4600B30076; 4600B30077; 4600B30078; 4600B30079; 4600B30080;
4600B30081; 4600B30082; 4600B30083; 4600B30084; 4600B30086; 4600C30087;
4600C30088; 4600C30089; 4600C30091; 4600C30092; 4600C30093; 4600C30094;
4600C30095; 4600C30096; 4600C30097; 4600C30098; 4600C30099; 4600D20035;
4600D20036; 4600D20037; 4600D20038; 4600D20039; 4600D20040; 4600D20041;
4600D20042; 4600D20043; 4600D20044; 4600H20045; 4600H20046; 4600H20047;
4600H20048; 4600H20049; 4600H20050; 4600H20051; 4600H20052; 4600H20053;
4600H20054; 4600I10013; 4600J20055; 4600J20056; 4600J20057; 4600J20058;
4600J20059; 4600J20060; 4600J20061; 4600J20062; 4600J20063; 4600J20064.
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ.
REASON
Failure of the Anestar AC Main Power Switch. Battery should last
30 minutes, then ventilation and monitoring will fail.
VOLUME OF PRODUCT IN COMMERCE
89 units.
DISTRIBUTION
Nationwide.
PRODUCT
Axiom Sensis Report Workstation.
CODE Serial Numbers 1002, 1034, 1100-1253, 1300-1504.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON
Software issue. Allows for users to enter date in Pre-Cath Holding
Area prior to registering the patient in the Cath Lab.
VOLUME OF PRODUCT IN COMMERCE
234 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge
Knee Tibial Component, precoat, nonmodular, size 2, sterile,
for cemented use only; Cat. No. 5880-02-02.
b) Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge
Knee Tibial Component, precoat, nonmodular, size 3, sterile,
for cemented use only; Cat No. 5880-03-02.
CODE
a) Lot 60037871; Exp, June 2008;
b) Lot 60004557; Exp. December 2008.
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN.
REASON
The polyethylene tibial bushing was omitted from the taper of the
tibial plates.
VOLUME OF PRODUCT IN COMMERCE
33
DISTRIBUTION
Nationwide and Germany.
PRODUCT
a) Axiom Artis BA or BC Biplane System, Angiographic x-ray
system. Model number 59 04 649.
b) Axiom Artis BA or BC Biplane System, Angiographic x-ray
system. Model number 59 04 656.
CODE
a) Serial numbers: 14002-14004, 14006-14012, 14014, 14018,
14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049,
14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071,
14074-14075, 14080-14081, 14084-14088, and 14092;
b) Serial numbers: 28000, and 28002-28118.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON
Opacification Function of device may incorrectly merge images.
VOLUME OF PRODUCT IN COMMERCE
71 units.
DISTRIBUTION
Nationwide.
PRODUCT
DANA Diabecare II insulin pumps.
CODE Serial numbers: AEE001FC – AEE039FC, AEE041FC, AEE043FC -
AEE048FC, AEE083FC – AEE132FC.
RECALLING FIRM/MANUFACTURER
Dana Diabecare USA LLC, New Orleans, LA.
REASON
There is a switch malfunction that may cause the unit not to respond
when command key is depressed.
VOLUME OF PRODUCT IN COMMERCE
37 units.
DISTRIBUTION
AZ, WV, PA, FL, WI, MI, TN, and MD.
PRODUCT
a) BV25 Mobile X-Ray System.
b) BV25 Gold Mobile X-Ray System.
c) BV26 Mobile X-Ray System.
d) BV29 Mobile X-Ray System.
e) BV212 Mobile X-Ray System.
CODE For all devices: Part #s 980762000001, 980762000101, 980762010001,
980762010101, 980762020001, 980762020201, 984910000031, 984910000101,
989600006051, 989600006091, 989600006281, 989600006282, 989600007041,
989600007731 Site #s 59630, 104099, 101968, 101961, 101964, 59628,
59631, 59632, 101967, 101963, X1118, X1178, X1463, X1346, X1190,
X1465, X0532, X1455, X1452, X1239, X1060, 300026, 300027, 13695,
10305, 13047, 13587, 13663, 35451, 13552, 15281, 13298, 13687, 14152,
13626, 15189, 13542, 15067, 10407, 13144, 15063, 14164, 13498, 13222,
13233, 13301, 15175, 13150, 82476, 15316, 13272, 5153, 13602, 15074,
14129, 15083, 13630, 82475, 13445, 10018, 15091, 59693, 13964, 13938,
13236, 4013, 6674, 6749, 59454, 6815, 6737, 6630, 6765, 6787, 81887,
6848, 5160, 6492, 4258, 6658, 6830, 6304, 101929, 6618, 6692, 6748,
4115, 6307, 6677, 4065, 4290, 6868, 6729, 4125, 6537, 6724, 6708,
4170, 6561, 76866, 5162, 5159, 4224, 6745, 5055, 6589, 34132, 34149,
35419, 38965, 35170, 34088, 34749, 34061, 35442, 34138, 34302, 34790,
67090, 61430, 34668, 504447, 35164, 35405, 81878, 34107, 34547,
34182, 34093, 41190, 61989, 31004, 34844, 34300, 35399, 34004, 31332,
67947, 35379, 35468, 16734, 17189, 17413, 17182, 16409, 17316, 16726,
16405, 16703, 41343, 41344, 16694, 17405, 16284, 16768, 16285, 16639,
17235, 17314, 17407, 16764, 16623, 17269, 16374, 16178, 17396, 17424,
17244, 16761, 16161, 17343, 16156, 16621, 16691, 16727, 17536, 16170,
17617, 17251, 17390, 16275, 61745, 17397, 17590, 81925, 16172, 61841,
17586, 76354, 16225, 16701, 17450, 17542, 16233, 17287, 17374, 16749,
16573, 16683, 17449, 17126, 16226, 16197, 17352, 16209, 16693, 17242,
17454, 17367, 17243, 17423, 62623, 62471, 61192, 17104, 17322, 17593,
17614, 76088, 17618, 76115, 17564, 16697, 10183, 17543, 87600, 76103,
17551, 37216, 76092, 17554, 16682, 76581, X0637, 17555, 76028, 17615,
76423, 16359, 16370, 40100, 17234, 17517, 17159, 16641, 16752, 16671,
16689, 16341, 16440, 16437, 17255, 16627, 16442, 16679, 86928, 76421,
76366, 76177, 76061, 17478, 17462, 17463, 86927, 76032, 67082, 17479,
17532, 76419, 76418, 17619, 17526, 100718, 17461, 76158, 76447,
76171, 6744, 76096, 76157, 6725, 76422, 76176, 76169, 76175, 76139,
17685, 84925, 16131, 16132, 17180, 16583, 17257, 16582, 17345, 16141,
16771, 13416, 15087, 16000, 13551, 17188, 13540, 16719, 16732, 17548,
17518, 82474, 16663, 17173, 16069, 16717, 16037, 16746, 16058, 16060,
17200, 17342, 16012, 16014, 17332, 16571, 17451, 16072, 59683, 17375,
16059, 16620, 16105, 82939, 17308, 16702, 16022, 17181, 16076, 16099,
59479, 84727, 13888, 13563, 13524, 13434, 13490, 13357, 10347, 13428,
13536, 10370, 13889, 13435, 15204, 13671, 13419, 10304, 13343, 13303,
13647, 15146, 44098, 10082, 13390, 10084, 10297, 82481, 84726, 15263,
15172, 15170, 59690, 13437, 10003, 15276, 13495, 13270, 15171, 10078,
19056, 62545, 61969, 19510, 38706, 62262, 61911, 38260, 61865, 19258,
19010, 62370, 19051, 62005, 62336, 19449, 62267, 68212, 84922, 19090,
19549, 62570, 62263, 61894, 19293, 62510, 62465, 62269, 61825, 62466,
61821, 61858, 14024, 104651, 19147, 62349, 6198, 6200, 6909, 76845,
76946, 6199, 6201, 6809, 6514, 10143, 104034, 13395, 6515, 44846,
6801, 6827, 6746, 6593, 59478, 6529, 6731, 6361, 84797, 6760, 6736,
6666, 25618, 6690, 6518, 6768, 6156, 6595, 10373, 15237, 13535,
15238, 13347, 10311, 13493, 43110, 13375, 15308, 10372, 15174, 10316,
13342, 10326, 13597, 15307, 13393, 10315, 13526, 10433, 15249, 13505,
13352, 13944, 13553, 15169, 10365, 13676, 10248, 13438, 13638, X1123,
505404, 504453, X1396, 81879, X1378, 84926, 81864, 84975, 81868,
81880, X0275, 81865, 84923, 81877, 250049, 84933, 81871, 250121,
X1530, 59685, 250833, 81888, 250774, 250047, X0555, X1513, 250818,
X1210, 37051, 37662, 37675, 37664, 37816, 37270, 37225, 37686, 37909,
37650, 38001, 37495, 37956, 37331, 37032, 37468, 37829, 37160, 37198,
37137, 37855, 37854, 37243, 37122, 37671, 37947, 37311, 37085, 37180,
37437, 37106, 43254, 37333, 37207, 37711, 37610, 37890, 100720,
37292, 37317, 38178, 37644, 37900, 37945, 37994, 37649, 38098, 59681,
35328, 59629, 34388, 34315, 35175, 34394, 34445, 35145, 41204, 35169,
34457, 35263, 35370, 35352, 41162, 34838, 35225, 31138, 35189, 35382,
35380, 35193, 31258, 100682, 34352, 41161, 41160, 35490, 37867,
62446, 37415, 37418, 37444, 37676, 37934, 37899, 37972, 37518, 37920,
37696, 37984, 37843, 504058, 37985, 37898, 37522, 37718, 37635,
37862, 37858, 37925, 37527, 37545, 83368, 37971, 37685, 38079, 37588,
37973, 37870, 37541, 37825, 37569, 37834, 37586, 37700, 37706, 37697,
37581, 37871, 37614, 37860, 37519, 37597, 37605, 37543, 37819, 37540,
37917, 37974, 37672, 37602, 37609, 37931, 37891, X0323, 35232, 34746,
35160, X0895, 35183, 34811, 35161, X1454, X0525, X0107, 104443,
X1451, 38886, X1244, 104428, X1461, 35242, X1462, 34692, 35353,
31044, 35174, 31147, X0896, 104433, 31078, 90025, 35467, 34664,
31075, 31272, 35440, 81855, 35367, 34217, 31033, 80304, 31241, 34682,
35316, 35393, 34831, 35224, 34689, 82685, 41159, 31232, 31184, 31024,
31054, 31185, 31016, 31011, 31260, 35178, 59567, 34752, 31097, 31145,
31233, 35092, 31106, 35262, 31230, 31144, 41365, 31069, 31098, 37993,
34794, 41175, 31090, 34832, 104252, 504111, 504110, 35611, 35610,
41203, 41187, 82472, 41205, X0651, 105468, X1263, 105593, 104405,
X0561, X0318, 104222, X0262, 104214, X0259, 104278, 506108, 104305,
X0527, X0188, 104290, X1350, 506614, X0266, X0315, X0314, 104262,
104258, 104320, 104226, 37921, 37902, 37361, 37677, 37669, 37367,
37505, 37399, 38150, 35582, 38151, 37349, 37645, 37362, 37388, 37659,
37373, 25030, 25946, 25108, 25610, 47067, 25185, 25963, 25092, 25852,
25169, 25074, 25944, 25880, 38436, 26033, 25960, 59625, 25068, 84832,
25896, 25816, 25942, 25812, 26167, 38432, 25212, 25594, 25810, 25066,
25861, 26078, 26000, 82625, 59688, 25797, 26146, 25654, 25819, 28271,
26115, 25857, 25818, 26096, 25617, 26079, 26112, 25352, 25378, 25382,
25771, 40008, 25622, 25593, 49479, 25957, 25840, 25869, 25703, 28280,
28262, 4130, 25879, 28275, 19150, 25590, 31117, 40005, 67070, 26083,
25339, 26002, 25323, 40232, 25956, 25624, 25542, 505557, 28230,
25844, 25620, 46013, 26034, 25436, 26284, 28244, 61877, 25507, 25677,
25438, 25985, 26132, 26049, 37976, 25437, 14111, 25280, 28273, 25411,
25916, 25283, 25274, 25678, 26087, 25906, 84473, 25982, 25277, 37577,
25180, 25188, 25996, 28152, 40970, 28130, 26054, 28094, 28217, 25659,
26084, 28277, 28104, 26050, 25831, 28022, 25913, 25914, 26104, 26097,
38383, 31123, 25894, 26013, 28054, 504444, 250409, 250415, 250414,
250416, X0273, 250465, 250455, 84918, X0342, X0306, X0319, X0291,
X1617, 250226, 504308, X0263, X0640, 250266, 504759, 505166, X1376,
250251, 250304, X1605, X0249, X0299, 13003, 250108, 19331, 62550,
62327, 19300, 82473, 61850, 19307, 61861, 38272, 62427, 62249, 62411,
62295, 19334, 19526, 19559, 62000, 61999, 62652, 19064, 58721, 65278,
59433, 83656, 59168, 81898, 59330, 43059, 81890, 58922, 59128, 81897,
58762, 84915, 58131, 59169, 58258, 58949, 59247, 58866, 81853, 58651,
81893, 58263, 84914, 84999, 59199, 59355, 81859, 81891, 58230, 59336,
58242, 58682, 84920, 59430, 59215, 81886, 84908, 81894, 58841, 58720,
84911, 59266, 59257, 59452, 58695, 58343, 59061, 58677, 59356, 58925,
58663, 59282, 58324, 59172, 59203, 59485, 59142, 101557, 68087,
67579, 68218, 67673, 67060, 67995, 67981, 67994, 68209, 68148, 67180,
38890, 67674, 68175, 68164, 67064, 67323, 85631, 59696, 82484, 4187,
38570, 10480, 59191, 13299, 58852, 82480, 38664, 82477, 59367, 59477,
104100, 59680, 58450, 58874, 17433, 83383, 59671, 82504, 58927,
84906, 10479, 58947, 104101, 104093, 59105, 84720, 10437, 13273,
38663, 504114, 59694, 58393, 84974, 58830, 59627, 83657, 59626,
59695, 59486, 59624, 104094, 59684, 82482, 59410, 83621, 82478,
6205, 59686, 59232, 10438, 59482, 59125, 82819, 38569, 58451, 82479,
84921, 83620, 83622, 58395, 59678, 59691, 59322, 82702, 59445, 59062,
61811, 59415, 61705, 61750, 61831, 61566, 61826, 61523, 62326, 61746,
61919, 62343, 62534, 61521, 61998, 85456, 82525, 61511, 62541, 58053,
59397, 59290, 59186, 59106, 59372, 58801, 59178, 59420, 101549,
58899, 59354, 58032, 58012, 58884, 67541, 68190, 67365, 67298, 68127,
68222, 67401, 67357, 67885, 67494, 67545, 68182, 68082, 67417, 67568,
67047, 38945, 67495, 68004, 61937, 62321, 62441, 62351, 61479, 38869,
61752, 61469, 61928, 61827, 62568, 61472, 61774, 62367, 62511, 62194,
61161, 61236, 61176, 61308, 61936, 62599, 62338, 62462, 61971, 62509,
62437, 62258, 62542, 61285, 61797, 62426, 61729, 62396, 61000, 67984,
61003, 62372, 62334, 62277, 62412, 61007, 84960, 61399, 62247, 62246,
62271, 61401, 68206, 62410, 61959, 67996, 38851, 61744, 61930, 59682,
62538, 61806, 67451, 81858, 67989, 67210, 67914, 81883, 67902, 68253,
38891, 67304, 67912, 67909, 68046, 81884, 67540, 67770, 67913, 68084,
67907, 504107, 67814, 67160, 67248, 68225, 67351, 67677, 67291,
67266, 67382, 67169, 68205, 68161, 67928, 68221, 67349, 34153, 67496,
67265, 67930, 67929, 67775, 68119, 38911, 68122, 68172, 67526, 67563,
67927, 67780, 67369, 68158, 67267, 67254, 67316, 67562, 38910, 41387,
67676, 67449, 38864, 67834, 68174, 65218, 37006, 73518, 73857, 73485,
73313, 37008, 37007, 64342, 37009, 64686, 73782, 73833, 73416, 73312,
59660, 37628, 64335, 73873, 64294, 65236, 73868, 65263, 64201, 65210,
73514, 73913, 64152, 64032, 64057, 65254, 64172, 74038, 65167, 64053,
74042, 73955, 64178, 73953, 64107, 82596, 73354, 65245, 81873, 73956,
65224, 73954, 6325, 64088, 64036, 64168, 73827, 64195, 73565, 38669,
59399, 73843, 81874, 74085, 64125, 64073, 64240, 38687, 73994, 73975,
64167, 73887, 74050, 64099, 65234, 73993, 64598, 64673, 58220, 64647,
65183, 73288, 64434, 73401, 73961, 64443, 64355, 64423, 74052, 65289,
82485, 64545, 74065, 73379, 64460, 65196, 73272, 73914, 64430, 38688,
73537, 73991, 64554, 73527, 73940, 64389, 64450, 73413, 73948, 64419,
64511, 64472, 64499, 65173, 65248, 65197, 73848, 64275, 64478, 500005,
64399, 64414, 73866, 73853, 100480, 73451, 64356, 64437, 64404,
59687, 64433, 64410, 64446, 73439, 65247, 64364, 64420, 73881, 6196,
6190, 6207, 6598, 6114, 6871, 6805, 6800, 6412, 6115, 6371, 6335,
6197, 6195, 6188, 6179, 6804, 6791, 84795, 6534, 6670, 6540, 6014,
6186, 84796, 6099, 6747, 6769, 6779, 6341, 59481, 6189, 76821, 6187,
X0563, X0562, X0558, X0559, X0535, X0538, X0258, X0564, X0526, X0311,
X0316, X0300, 10067, X0301, X0906, X0092, 6487, X0547, X0549, X0519,
X0548, X0551, X0313, X0560, X0552, 64514, 44731, 49166, 50170, 44847,
49627, 50093, 43442, 49596, 44856, 44561, 44849, 84917, 74082, 44704,
43025, 49165, 44758, 49296, 44756, 49692, 50144, 44984, 49229, 49718,
49075, 49182, 50092, 49282, 49260, 49185, 49183, 49172, 50049, 49257,
49731, 50041, 49154, 49706, 50106, 49179, 44961, 50133, 44853, 49292,
49714, 83032, 58379, 50123, 49353, 50198, 50005, 49031, 50124, 49580,
49728, 49387, 49499, 50071, 49683, 44762, 50082, 44775, 49673, 84919,
50084, 50000, 50172, 59689, 49607, 49459, 49048, 50001, 50059, 49373,
81876, 50008, 49726, 50040, 49400, 81889, 49376, 83835, 49685, 49118,
44234, 43758, 43291, 43236, 44072, 43094, 44265, 44855, 44637, 43999,
43295, 44702, 43274, 44317, 44881, 43006, 43739, 44227, 44016, 44874,
44638, 43005, 44015, 44207, 44789, 43348, 81856, 44617, 43822, 44700,
43262, 44025, 43744, 44165, 43168, 44102, 43355, 44289, 300566,
43368, 43196, 43353, 43824, 44243, 43370, 44087, 44616, 43823, 44241,
44110, 81854, 43995, 43165, 44240, 44294, 44222, 43959, 43371, 43086,
44309, 43215, 43286, 43950, 43345, 44643, 44171, 44009, 43720, 44050,
44720, 44666, 43475, 47130, 44778, 44201, 44764, 50138, 44776, 49341,
40026, 46295, 46240, 82501, 46410, 46271, 46325, 46060, 46059, 46487,
38334, 46006, 47093, 40114, 46090, 46097, 47153, 46957, 40124, 46104,
46111, 46272, 46036, 46888, 47111, 46072, 46327, 40910, 83959, 47179,
46101, 46100, 47064, 46958, 46575, 40331, 47119, 40424, 59677, 46371,
46945, 40744, 47183, 47184, 38277, 47011, 40121, 40135, 46495, 53072,
40772, 40775, 40444, 40165, 46546, 46622, 40120, 47024, 46416, 46988,
40319, 40070, 47142, 41039, 40076, 83902, 61837, 46478, 40146, 53073,
40293, 47030, 40715, 46992, 47129, 47096, 46966, 40036, 83006, 47010,
40274, 40391, 47143, 47001, 40485, 81895, 40820, 84927, 47088, 40640,
46415, 40214, 40242, 47170, 40199, 46965, 40268, 40186, 40362, 46414,
40227, 40395, 505644, 47003, 46938, 40239, 40251, 46361, 40266,
40700, 40827, 46662, 40255, 47104, 46544, 40363, 40228, 40183, 50391,
46625, 40359, 46402, 100019, 46914, 46912, 40335, 40776, 46429,
40384, 46850, 46937, 40336, 40193, 46953, 46522, 46365, 40351, 40155,
47038, 46523, 46989, 40294, 46939, 40247, 46858, 40747, 46843, 40347,
46554, 46627, 47063, 47059, 40349, 47004, 40817, 46962, 47081, 47268,
44875, 40808, 46623, 40012, 46976, 40322, 40080, 44678, 40047, 40288,
40943, 40049, 100315, 46514, 40337, 40942, 40380, 59622, 40855,
40299, 81928, 47049, 47181, 46253, 81927, 46431, 44725, 46934, 47074,
6991, 46181, 46210, 46285, 46549, 46127, 46128, 46200, 46307, 16765,
81929, 46157, 41006, 40018, 40042, 46214, 46291, 46842, 46223, 47008,
47118, 46923, 46290, 47079, 46230, 47120, 46221, 44724, 43895, 505766,
44880, 44613, 44600, 44088, 43617, 44601, 44765, 43382, 44622, 44583,
43615, 43531, 44209, 101672, 44198, 44210, 44052, 6151, 101671,
43908, 43042, 4284, 44811, 43668, 44741, 43558, 59623, 43556, 17245,
13681, 10068, 13581, 16152, 15295, 13451, 15075, 6237, 6823, 13468,
13541, 81881, 6999, 15288, 15210, 13477, 4229, 13386, 15078, 15290,
13588, 10312, 37472, 13694, 13668, 13746, 76899, 26067, 13422, 52359,
59704, 67879.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America,
Bothell, WA.
REASON
Potential for c-arm to move due to loose screws.
VOLUME OF PRODUCT IN COMMERCE
1,900 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Jackson Original Stainless Steel Tracheostomy Tubes, item
number 1034300 size 00, item number 1034310 size 0, item
number 1034311 size 1, item number 1034312 size 2, item
number 1034313 size 3, item number 1034314 size 4, item
number 1034315 size 5, item number 1034316 size 6, item
number 1034317 size 7, item number 1034318 size 8, item
number 1034319 size 9, item number 1034320 size 10.
b) Jackson Original Short Stainless Steel Tracheostomy Tubes,
item number 1034600 size 00, item number 1034610 size 0, item
number 1034611 size 1, item number 1034612 size 2, item
number 1034613 size 3, item number 1034614 size 4, item
number 1034615 size 5, item number 1034616 size 6, item
number 1034617 size 7, item number 1034618 size 8, item
number 1034619 size 9, item number 1034620 size 10.
c) Jackson Improved Stainless Steel Tracheostomy Tubes, item
number 1034900 size 00, item number 1034910 size 0, item
number 1034911 size 1, item number 1034912 size 2, item
number 1034913 size 3, item number 1034914 size 4, item
number 1034915 size 5, item number 1034916 size 6, item
number 1034917 size 7, item number 1034918 size 8, item
number 1034919 size 9, item number 1034920 size 10.
d) Jackson Improved Short Stainless Steel Tracheostomy
Tubes, item number 8100465 size 1, item number 8100373
size 3, item number 1034924 size 4, item number 1034925
size 5, item number 1034926 size 6, item number 1034927
size 7, 1034928 size 8, item number 8100468 size 9,
item number 8100234 size 10.
e) Jackson Improved Short Stainless Steel Tracheostomy
Tubes, item number 1034930 size 00, item number 1034940
size 0, item number 1034941 size 1, item number 1034942
size 2, item number 1034943 size 3, item number 1034944
size 4, item number 1034945 size 5, item number 1034946
size 6, item number 1034947 size 7, item number 1034948
size 8, item number 1034949 size 9, item number 1034950
size 10.;
f) Jackson Improved Short Stainless Steel with Adapter
Tracheostomy Tubes, item number 8100402 size 3,
item number 8100040 size 4, item number 8100041 size 5,
item number 8100229 size 6, item number 8100322 size 7,
item number 8100374 size 8, item number 8100282 size 9,
and item number 8100709 size 10.
g) Jackson Improved Extra Long Stainless Steel Tracheostomy
Tubes, item number 1034964 size 4, item number 1034965
size 5, item number 1034966 size 6, item number 1034967
size 7, item number 1034968 size 8, item number 1034969
size 9, and item number 1034970 size 10.
h) Air Lon Nylon, Tracheostomy Tubes, item number 1050150 size
3, item number 1050152 size 4, item number 1050154 size 5,
item number 1050156 size 6, item number 1050158 size 7, and
item number 1050160 size 8.
i) Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter)
Nylon, Tracheostomy Tubes, item number 1050180 size 3, item
number 1050182 size 4, item number 1050184 size 5, item
number 1050186 size 6, item number 1050188 size 7, and item
number 1050190 size 8.
j) Laryngectomy Tubes, Martin Stainless Steel, item number
1036128 size 8 and item number 1036130 size10.
k) Jackson Original Stainless Steel Laryngectomy Tubes, item
number 1037214 size 4, item number 1037215 size 5, item
number 1037216 size 6, item number 1037217 size 7, item
number 1037218 size 8, item number 1037219 size 9, and item
number 1037220 size 10.
l) Laryngectomy Tubes, Jackson Improved Stainless Steel, item
number1037414 size 4, item number 1037415 size 5, item number
1037416 size 6, item number 1037417 size 7, item number
1037418 size 8, item number 1037419 size 9, and item number
1037420 size 10.
m) Air Lon Nylon Laryngectomy Tubes, item number1050170 size 8
and item number 1050172 size 10.
n) Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter)
Nylon Laryngectomy Tubes, item number 1050200 size 8 and item
number 1050202 size 10.
CODE All lots.
RECALLING FIRM/MANUFACTURER
Premier Dental Products Co., Plymouth Meeting, PA.
REASON
Foreign objects (polishing stones) in the tubes.
VOLUME OF PRODUCT IN COMMERCE
22,324 tubes.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Zoll M Series Automated Defibrillator (AED).
CODE Software Versions below 34.00.
RECALLING FIRM/MANUFACTURER
Zoll Medical Corp., Chelmsford, MA.
REASON
Visual Screen display and audible prompt may not advise to “Press
Shock”.
VOLUME OF PRODUCT IN COMMERCE
5,649 units.
DISTRIBUTION
Nationwide.
PRODUCT
XSYSTEMS Dilution Buffer, list number 9519-02, for In Vitro diagnostic
use, Bovine gamma globulin in Phosphate buffer, with Siduyn Azude
as a oreservatuvem 950 mL bottle, 4 bottles per carton.
CODE List number 9519-02, all lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON
The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines
assay can cause shifts in control values and patient results.
VOLUME OF PRODUCT IN COMMERCE
22,442 cartons.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Siregraph CF X-Ray System. Fluoroscopic image intensified.
Model number 4466033.
b) Siregraph CF X-Ray System. Fluoroscopic image intensified.
Model number 4466041.
CODE
a) Serial numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1572,
1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.
b) Serial number: 3131.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON
Unintended X-ray tube movement when table is tilted more than 90
degrees.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
FL, IL, MI, NH, NJ, PA, and TX.
PRODUCT
ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
CODE Lot #910718.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa KS.
REASON
A potential contamination was noted in the conjugate in ProSpecT
Campylobacter Microplate Assay. The particulate in the conjugate
may cause the dropper tip to become plugged.
VOLUME OF PRODUCT IN COMMERCE
382.
DISTRIBUTION Russelsheim, Germany.
PRODUCT
a) Manual Biopsy Devices containing AIM system: Chiba Needle, 6
inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021
(10 per box).
b) Manual Biopsy Devices containing AIM system: Chiba Needle,
8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031
(10 per box).
c) Manual Biopsy Devices containing AIM system: Crown Biopsy
Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material
#M001404041 (10 per box).
d) Manual Biopsy Devices containing AIM system: Co-Axial Lung
Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material
#M001406001 (5 per box).
CODE
a) 6503654, 6513396, 6544512;
b) 6503081, 6507526;
c) 6528003, 6577339;
d) 6528009.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Natick, MA.
REASON
Incomplete graduation on the needle guard, which would cause the
graduations to be off by as much as 1 cm.
VOLUME OF PRODUCT IN COMMERCE
186 cartons.
DISTRIBUTION
Nationwide and Italy.
PRODUCT ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests).
CODE
List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300;
List 6C09-25, lots 11002M301, 16051M201, 18288M301.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON
Changes in the ARCHITECT B12 Reagent lots may adversely affect the
shape of the calibration curve, over time. These changes may produce
controls out of range low and similar decreases in patient sample
values prior to current expiration of the reagents.
VOLUME OF PRODUCT IN COMMERCE
5,754 kits.
DISTRIBUTION
Internationally.