MARCH 2005
WEEK ENDING MARCH 5
PRODUCT
Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System
(CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid
Exchange Delivery System (CXSxxxxx).
CODE
All Cypher product CWSxxxxx and CXSxxxxx available for inspection at U.S. hospitals
between 11/17/2004 and 12/16/2004.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL
REASON
Inventory control stickers had incorrect expiration date. The stickers stated
the expiration date was November 2004 instead of October 2004.
VOLUME OF PRODUCT IN COMMERCE
29,133 Stents inspected.
DISTRIBUTION
Nationwide.
PRODUCT
The Triathlon Posteriorly Stabilized Femoral Component.
CODE
Catalog Number--Lot Code: 5511-F-301--ER0215;
5511-F-301--PR04139; 5511-F-301--PR04664;
5511-F-301--PR04862; 5511-F-301--PR04891;
5511-F-301--PR04955; 5511-F-301--PR41122;
5511-F-301--PR4352; 5511-F-301--PR4424;
5511-F-301--PR4425; 5511-F-301--PR4427;
5511-F-301--PR4519; 5511-F-301--PR4734;
5511-F-301--PR4736; 5511-F-302--ER0184;
5511-F-302--PR04795; 5511-F-302--PR04808;
5511-F-302--PR04809; 5511-F-302--PR04810;
5511-F-302--PR04840; 5511-F-302--PR04887;
5511-F-302--PR04902; 5511-F-302--PR4113;
5511-F-302--PR41142; 5511-F-302--PR41143;
5511-F-302--PR4256; 5511-F-302--PR42561;
5511-F-302--PR4429; 5511-F-302--PR4430;
5511-F-302--PR4432; 5511-F-302--PR4520;
5511-F-302--PR4727; 5511-F-302--PR4738;
5511-F-302--PR4739; 5511-F-302--PR4774;
5511-F-302--PRO4626; 5511-F-302--PRO4627;
5511-F-302--PRO4629; 5511-F-401--PR04811;
5511-F-401--PR04848; 5511-F-401--PR04849;
5511-F-401--PR04865; 5511-F-401--PR04866;
5511-F-401--PR04867; 5511-F-401--PR04881;
5511-F-401--PR04882; 5511-F-401--PR4107;
5511-F-401--PR41073; 5511-F-401--PR4115;
5511-F-401--PR4435; 5511-F-401--PR4437;
5511-F-401--PR4718; 5511-F-401--PR4740;
5511-F-401--PR4775; 5511-F-401--PR4779;
5511-F-402--ER0219; 5511-F-402--PR04805;
5511-F-402--PR04805; 5511-F-402--PR04806;
5511-F-402--PR04850; 5511-F-402--PR04851;
5511-F-402--PR04880; 5511-F-402--PR04905;
5511-F-402--PR04906; 5511-F-402--PR4116;
5511-F-402--PR4258; 5511-F-402--PR4440;
5511-F-402--PR4442; 5511-F-402--PR4443;
5511-F-402--PR4716; 5511-F-402--PR4728;
5511-F-402--PR4777; 5511-F-501--ER0217;
5511-F-501--ER0250; 5511-F-501--PR4117;
5511-F-501--PR4118; 5511-F-501--PR4254;
5511-F-501--PR42541; 5511-F-501--PR42593;
5511-F-501--PR4418; 5511-F-501--PR4444;
5511-F-501--PR4445; 5511-F-501--PR4446;
5511-F-501--PR4448; 5511-F-501--PR4449;
5511-F-501--PR4450; 5511-F-501--PR4452;
5511-F-501--PR4524; 5511-F-501--PR4767;
5511-F-502--ER0218; 5511-F-502--PR04884;
5511-F-502--PR04885; 5511-F-502--PR05008;
5511-F-502--PR41191; 5511-F-502--PR41194;
5511-F-502--PR4379; 5511-F-502--PR4456;
5511-F-502--PR4457; 5511-F-502--PR4458;
5511-F-502--PR4459; 5511-F-502--PR4460;
5511-F-502--PR4461; 5511-F-502--PR4525;
5511-F-502--PR4526; 5511-F-502--PR4527;
5511-F-502--PR4768; 5511-F-502--PR4778;
5511-F-601--ER0185; 5511-F-601--ER0280;
5511-F-601--PR04886; 5511-F-601--PR04904;
5511-F-601--PR05021; 5511-F-601--PR05052;
5511-F-601--PR05229; 5511-F-601--PR41421;
5511-F-601--PR41422; 5511-F-601--PR41423;
5511-F-601--PR4464; 5511-F-601--PR4528;
5511-F-601--PR4529; 5511-F-601--PR4752;
5511-F-601--PR4753; 5511-F-601--PR4798;
5511-F-601--PR5026; 5511-F-601--PR5032;
5511-F-601--PR5037; 5511-F-601--PR5046;
5511-F-601--PR5108; 5511-F-601--PR5110;
5511-F-602--ER0186; 5511-F-602--ER0253;
5511-F-602--ER0254; 5511-F-602--ER0265;
5511-F-602--J66915; 5511-F-602--PR04662;
5511-F-602--PR04828; 5511-F-602--PR04863;
5511-F-602--PRO4864; 5511-F-602--PR4099;
5511-F-602--PR42731; 5511-F-602--PR4470;
5511-F-602--PR4471; 5511-F-602--PR4472;
5511-F-602--PR4754; 5511-F-602--PR4757;
5511-F-602--PR4772; 5511-F-602--PR4776;
5511-F-602--PR4781; 5511-F-602--PR4901;
5511-F-602--PR5111; 5511-F-602--PR5112.
Several units of the same lot number are reported in the quantity distributed.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ
REASON
The fatigue testing of the Triathlon PS Femoral Component does not consistently
meet the requirements of the finite element analysis predicted load as delineated
in the 510(k) submittal.
VOLUME OF PRODUCT IN COMMERCE
386 units.
DISTRIBUTION
Nationwide.
WEEK ENDING MARCH 12
PRODUCT
a) Heparin Lock Flush Solution.
b) Sodium Chloride Injection USP.
CODE
All lots remaining on the market.
RECALLING FIRM/MANUFACTURER
IV Flush LLC, Rowlett, TX
REASON
Device marketed without 510(k) clearance and is suspected to be contaminated
with P. Fluorescens.
VOLUME OF PRODUCT IN COMMERCE
Approximately 4,028 cases of 120 syringes each.
DISTRIBUTION
Nationwide.
PRODUCT
Sterile Empty Vials for Allergenic Extracts, 100ml size.
CODE
Item #SE08160, Lot 9406.
RECALLING FIRM/MANUFACTURER
Greer Laboratories, Inc., Lenoir, NC
REASON
Product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
2,157 vials.
DISTRIBUTION
Nationwide.
PRODUCT
Model 8100 Series Medley Medication Safety System Pump Module.
CODE
Serial Numbers 2326101 thru 9861567.
RECALLING FIRM/MANUFACTURER
Alaris Medical Systems Inc, San Diego, CA
REASON
The device modification is being implemented in response to information received
from the field regarding a specific method of misloading the medication administration
tubing set into the infusion system pump module.
VOLUME OF PRODUCT IN COMMERCE
55,200 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Flexiflo Quantum Enteral Pump.
CODE
Serial #1061305 through 1061455, Serial #1061486 through 1061505, Serial # 1061507
through 1061512, Serial #1061705 through 1061726.
RECALLING FIRM/MANUFACTURER
Ross Products Division Abbott Laboratories, Columbus, OH
REASON
Pumps were manufactured with an incorrect circuit board that may cause an increase
in the feed rate and flush frequency of fluids.
VOLUME OF PRODUCT IN COMMERCE
199 units.
DISTRIBUTION
Nationwide.
PRODUCT
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704.
CODE
All units with the Serial Numbers 24578 and lower.
RECALLING FIRM/MANUFACTURER Maquet, Inc, Bridgewater, NJ
REASON
Failures of the air and oxygen gas modules occurred because of misuse/non-compliance
of directions.
VOLUME OF PRODUCT IN COMMERCE
7,905 units.
DISTRIBUTION
Nationwide.
PRODUCT
Varcella Zoster ELISA kit for the detection of IgG antibodies to varicella zoster
virus in human serum, Catalog No.: 4620.
CODE
Lot # 111261.
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN
REASON
Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000
automated microtiter plate instrument and/or false negative results.
VOLUME OF PRODUCT IN COMMERCE
99 kits.
DISTRIBUTION
AL, CA, IL, KS, MA, MI and NJ.
PRODUCT
a) BioTek brand Automated Microplate Reader;
Model Elx800, Roche catalog number 21045059001.
b) BioTek brand Automated Microplate Reader;
Model Elx808, Roche catalog number 03145387001.
CODE
All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters
by Roche for use with the Roche HCV test version 2-0.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN
REASON
The parameters loaded in the analyzer for the hepatitis C virus do not match
those in the package insert, and patient results may be reported out as false
positives or false negatives.
VOLUME OF PRODUCT IN COMMERCE
216 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged;
Made in China; UPC 31262-00789, Deals Nothing Over A Dollar SKU #100608494.
The individually packaged toothbrushes are packaged 49 per case labeled as Decent
Trading Adult Battery Operated Toothbrush.
CODE
All lots distributed between 10/22/04 and 2/3/05.
RECALLING FIRM/MANUFACTURER
Deals Nothing Over A Dollar, Earth City, MO
REASON
A defective seal allows water into the handle of the toothbrush via the bristles,
and rusty water seeps back out of the toothbrush around the bristles.
VOLUME OF PRODUCT IN COMMERCE
10,535 toothbrushes.
DISTRIBUTION
Nationwide.
PRODUCT
Access Immunoasay Systems Digoxin Reagent.
CODE
Lots 323171; 416110; 417703 and 419534.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA
REASON
Variability in results on Patient and QC results of 20-25%, high and low.
VOLUME OF PRODUCT IN COMMERCE
4,352.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin).
NDC 81306-0515-23.
CODE
Batch # 4083690.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ
REASON
Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch
product (28 ga).
VOLUME OF PRODUCT IN COMMERCE
1,543,000 syringes.
DISTRIBUTION
AR.
WEEK ENDING MARCH 19
PRODUCT
LIFEPAK 500 AED.
CODE
Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX,
U3005400-XXX.
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA
REASON
Potential to not detect patients at the low end of the patient impedance range.
VOLUME OF PRODUCT IN COMMERCE
1,953 devices.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch,
part number 32901, the breather pouch measures 25.25 inches x 30.75 inches,
5 mil thick.
CODE
Lot numbers 44134-01 and 43589-01; all lots distributed between 6/15/04 and
3/1/05 of the following reorder numbers: DYNJ02170A, DYNJ02176A, DYNJ02179B,
DYNJ02182A, DYNJ04314A, DYNJ04316, DYNJ04321, DYNJ04325, DYNJ04329, DYNJ04336B,
DYNJ04338B, DYNJ04371, DYNJ04383, DYNJ04388, DYNJ04407A, DYNJ04408A, DYNJ04419A,
DYNJ04427, DYNJ04455, DYNJ04468B, DYNJ04472A, DYNJ04476, DYNJ04478A, DYNJ04481B,
DYNJ04482, DYNJ04483, DYNJ04485, DYNJ04494, DYNJ04497, DYNJ04502, DYNJ04504,
DYNJ04505, DYNJ04509, DYNJ04542, DYNJ04545, DYNJ04548A, DYNJ04556A, DYNJ04557B,
DYNJ04558A, DYNJ04572, DYNJ04579A, DYNJ04597, DYNJ04609, DYNJ04611A, DYNJ04620A,
DYNJ04629B, DYNJ04676A, DYNJ04677, DYNJ04683, DYNJ04691, DYNJ04709A, DYNJ04710,
DYNJ04711, DYNJ04711A, DYNJ04712, DYNJ04713A, DYNJ04720A, DYNJ04723, DYNJ04729,
DYNJ04744, DYNJ04745A, DYNJ04754A, DYNJ04805A, DYNJ04807A, DYNJ04811, DYNJ04822A,
DYNJ04825A, DYNJ04832, DYNJ04834, DYNJ04840, DYNJ04841, DYNJ04878, DYNJ04880,
DYNJ04888, DYNJ05787K, DYNJ05798K, DYNJ06075G, DYNJ06324L, DYNJ06682B, DYNJ06739B,
DYNJ06743A, DYNJ06744B, DYNJ06782A, DYNJ06796J, DYNJ06839A, DYNJ06873A, DYNJ06876D,
DYNJ06876F, DYNJ06908B, DYNJ06927A, DYNJ06930F, DYNJ06952F, DYNJ06976, DYNJ07536,
DYNJ07537C, DYNJ07626A, DYNJ07626A, DYNJ07626A, DYNJ07670C, DYNJ07833F, DYNJ07881C,
DYNJ07910A, DYNJ07942, DYNJ07942, DYNJ07951A, DYNJ07954A, DYNJ07954A, DYNJ07982A,
DYNJ07995, DYNJ08351K, DYNJ08387F, DYNJ08601A, DYNJ08671I, DYNJ08713C, DYNJ08796D,
DYNJ08802, DYNJ08814F, DYNJ08815D, DYNJ08816C, DYNJ08840J, DYNJ08844I, DYNJ09066C,
DYNJ09156F, DYNJ09174D, DYNJ09188A, DYNJ09194F, DYNJ09258R, DYNJ09259I, DYNJ09261J,
DYNJ09294B, DYNJ09322D, DYNJ09343F, DYNJ09346, DYNJ09397A, DYNJ09398, DYNJ09449C,
DYNJ09515C, DYNJ09528D, DYNJ09531D, DYNJ09532F, DYNJ09533F, DYNJ09590D, DYNJ09617B,
DYNJ09619D, DYNJ09624A, DYNJ09677A, DYNJ09677C, DYNJ09681C, DYNJ09682B, DYNJ09684B,
DYNJ09694A, DYNJ09703B, DYNJ09787B, DYNJ09807K, DYNJ09857B, DYNJ09858A, DYNJ09874C,
DYNJ09875G, DYNJ09882A, DYNJ09921, DYNJ09923, DYNJ09932B, DYNJ09933, DYNJ09941C,
DYNJ09981A, DYNJ14000A, DYNJ14002, DYNJ14005A, DYNJ14006, DYNJ14008A, DYNJ14014,
DYNJ14017A, DYNJ14018A, DYNJ14024, DYNJ14038, DYNJ14039, DYNJ14069A, DYNJ14078A,
DYNJ14079, DYNJ14095A, DYNJ14096B, DYNJ14097, DYNJ14107, DYNJ14107, DYNJ14110,
DYNJ14112A, DYNJ14114, DYNJ14119, DYNJ14127, DYNJ14130, DYNJ14134, DYNJ14137,
DYNJ14147A, DYNJ14148A, DYNJ14149A, DYNJ14150A, DYNJ14156B, DYNJ14157B, DYNJ14170,
DYNJ14187, DYNJ14218A, DYNJ14225A, DYNJ15062, DYNJ15332A, DYNJ15392D, DYNJ15393G,
DYNJ15428F, DYNJ15455P, DYNJ15494A, DYNJ15504D, DYNJ15519A, DYNJ15615D, DYNJ15643L,
DYNJ15660C, DYNJ15660D, DYNJ15668D, DYNJ15703A, DYNJ15751C, DYNJ15752, DYNJ15814I,
DYNJ15903C, DYNJ15956B, DYNJ15980A, DYNJ16018F, DYNJ16025B, DYNJ16026B, DYNJ16065A,
DYNJ16072D, DYNJ16076I, DYNJ16079B, DYNJ16082B, DYNJ16114F, DYNJ16127C, DYNJ16131B,
DYNJ16206A, DYNJ16250C, DYNJ16263C, DYNJ16274B, DYNJ16280B, DYNJ16284, DYNJ16289B,
DYNJ16327C, DYNJ16327D, DYNJ16342, DYNJ16346A, DYNJ16350C, DYNJ16376C, DYNJ16379B,
DYNJ16381C, DYNJ16384, DYNJ16435, DYNJ16461C, DYNJ16510D, DYNJ16514B, DYNJ16518A,
DYNJ16535A, DYNJ16536A, DYNJ16541B, DYNJ16567C, DYNJ16575, DYNJ16577, DYNJ16589,
DYNJ16591, DYNJ16604, DYNJ16604A, DYNJ16623, DYNJ16625, DYNJ16644, DYNJ17003A,
DYNJ17008, DYNJ17016A, DYNJ17018, DYNJ17020, DYNJ17042, DYNJ17044, DYNJ17045A,
DYNJ17053, DYNJ17065, DYNJ17068, DYNJ17082, DYNJ19022D, DYNJ19023C, DYNJ19029A,
DYNJ19051B, DYNJ19061D, DYNJ19069B, DYNJ19073B, DYNJ19081D, DYNJ19109A, DYNJ19121,
DYNJ19138C, DYNJ19139A, DYNJ19146C, DYNJ19146D, DYNJ19154B, DYNJ19170B, DYNJ19199A,
DYNJ19230D, DYNJ19233B, DYNJ19234B, DYNJ19235A, DYNJ19249B, DYNJ19251A, DYNJ19256B,
DYNJ19257A, DYNJ19296C, DYNJ19329C, DYNJ19371, DYNJ19390B, DYNJ19395B, DYNJ19416B,
DYNJ19418D, DYNJ19419A, DYNJ19419B, DYNJ19441D, DYNJ19451I, DYNJ19461B, DYNJ19468A,
DYNJ19469, DYNJ19479A, DYNJ19483, DYNJ19500A, DYNJ19501B, DYNJ19509C, DYNJ19515,
DYNJ19527D, DYNJ19529A, DYNJ19550A, DYNJ19551B, DYNJ19564A, DYNJ19589A, DYNJ19590A,
DYNJ19603B, DYNJ19611B, DYNJ19612B, DYNJ19620A, DYNJ19637G, DYNJ19638F, DYNJ19646D,
DYNJ19655A, DYNJ19657, DYNJ19674B, DYNJ19675D, DYNJ19679D, DYNJ19684A, DYNJ19686,
DYNJ19694A, DYNJ19696A, DYNJ19697A, DYNJ19699A, DYNJ19709C, DYNJ19710B, DYNJ19724A,
DYNJ19726A, DYNJ19729A, DYNJ19730B, DYNJ19738, DYNJ19771B, DYNJ19775A, DYNJ19777A,
DYNJ19777A, DYNJ19787B, DYNJ19788A, DYNJ19789A, DYNJ19790B, DYNJ19791D, DYNJ19804B,
DYNJ19813, DYNJ19814A, DYNJ19816A, DYNJ19830, DYNJ19833, DYNJ19842A, DYNJ19850B,
DYNJ19853, DYNJ19880B, DYNJ19882B, DYNJ19885B, DYNJ19887B, DYNJ19888, DYNJ19900C,
DYNJ19901D, DYNJ19907, DYNJ19910, DYNJ19918B, DYNJ19919B, DYNJ19923, DYNJ19929A,
DYNJ19929B, DYNJ19933G, DYNJ19935F, DYNJ19938, DYNJ19944, DYNJ19949A, DYNJ19951B,
DYNJ19953A, DYNJ19955A, DYNJ19960B, DYNJ19964B, DYNJ19981A, DYNJ19997F, DYNJ20004F,
DYNJ20007C, DYNJ20010A, DYNJ20012A, DYNJ20013A, DYNJ20020A, DYNJ20021A, DYNJ20026A,
DYNJ20027A, DYNJ20028A, DYNJ20029, DYNJ20030B, DYNJ20031, DYNJ20034, DYNJ20040A,
DYNJ20053B, DYNJ20055A, DYNJ20079A, DYNJ20081A, DYNJ20084, DYNJ20104, DYNJ20106A,
DYNJ20107, DYNJ20114C, DYNJ20115, DYNJ20117, DYNJ20124A, DYNJ20125, DYNJ20126A,
DYNJ20127A, DYNJ20134B, DYNJ20135C, DYNJ20137A, DYNJ20138B, DYNJ20142A, DYNJ20151B,
DYNJ20169, DYNJ20170, DYNJ20181, DYNJ20185, DYNJ20186, DYNJ20187A, DYNJ20198A,
DYNJ20200, DYNJ20202A, DYNJ20208, DYNJ20211A, DYNJ20213A, DYNJ20214A, DYNJ20215A,
DYNJ20216, DYNJ20218A, DYNJ20221A, DYNJ20230, DYNJ20232, DYNJ20248B, DYNJ20252,
DYNJ20335A, DYNJ20354A, DYNJ20355B, DYNJ20397A, DYNJ20405, DYNJ20409, DYNJ20422,
DYNJ20425B, DYNJ20433, DYNJ20440A, DYNJ20441, DYNJ20442, DYNJ20462B, DYNJ20463,
DYNJ20465B, DYNJ20466A, DYNJ20468B, DYNJ20472B, DYNJ20485B, DYNJ20487B, DYNJ20488B,
DYNJ20489, DYNJ20489B, DYNJ20490A, DYNJ20491B, DYNJ20495B, DYNJ20496A, DYNJ20498A,
DYNJ20498B, DYNJ20502B, DYNJ20503A, DYNJ20507A, DYNJ20508A, DYNJ20509B, DYNJ20518C,
DYNJ20521A, DYNJ20522, DYNJ20522A, DYNJ20540B, DYNJ20567B, DYNJ20567B, DYNJ20609A,
DYNJ20609B, DYNJ20639A, DYNJ20643A, DYNJ20696A, DYNJ20738, DYNJ20767B, DYNJ20775B,
DYNJ20788B, DYNJ20789B, DYNJ20792, DYNJ20792, DYNJ20794, DYNJ20797A, DYNJ20806A,
DYNJ20810, DYNJ20829A, DYNJ20834, DYNJ20838A, DYNJ20844A, DYNJ20846A, DYNJ20870,
DYNJ20872A, DYNJ20888A, DYNJ20890A, DYNJ20891A, DYNJ20899, DYNJ20910, DYNJ20911A,
DYNJ20913, DYNJ20928B, DYNJ20932B, DYNJ20933A, DYNJ20942A, DYNJ20955, DYNJ20994,
DYNJ21003, DYNJ21011B, DYNJ21016, DYNJ21018, DYNJ21019A, DYNJ21020B, DYNJ21030,
DYNJ21049A, DYNJ21063A, DYNJ21073B, DYNJ21088C, DYNJ21096, DYNJ21097, DYNJ21100A,
DYNJ21123, DYNJ21140, DYNJ21149, DYNJ21149A, DYNJ21175A, DYNJ21183, DYNJ21187A,
DYNJ21190, DYNJ21191, DYNJ21193, DYNJ21226, DYNJ21249, DYNJ21265, DYNJ21294A,
DYNJ21296A, DYNJ21304, DYNJ21307A, DYNJ21307B, DYNJ21320, DYNJ21322, DYNJ21324B,
DYNJ21327A, DYNJ21328B, DYNJ21329A, DYNJ21378, DYNJ21399A, DYNJ21400, DYNJ21404B,
DYNJ21405A, DYNJ21406A, DYNJ21425, DYNJ21451A, DYNJ21452, DYNJ21475, DYNJ21476,
DYNJ21484, DYNJ21485, DYNJ21491, DYNJ21494, DYNJ21497, DYNJ21497A, DYNJ21511,
DYNJ21513, DYNJ21526, DYNJ21527, DYNJ21529, DYNJ21530, DYNJ21540, DYNJ21545,
DYNJ21557, DYNJ21562, DYNJ21567, DYNJ21569, DYNJ21584, DYNJ21601, DYNJ21633,
DYNJ21635, DYNJ21635A, DYNJ21677, DYNJ21718, DYNJ21721, DYNJ21722, DYNJ21726,
DYNJ21728, DYNJ21736, DYNJ21737, DYNJ21739, DYNJ21777A, DYNJ21785, DYNJ21792A,
DYNJ21797, DYNJ21798, DYNJ21803, DYNJ21804, DYNJ21805, DYNJ21817, DYNJ21818,
DYNJ21826, DYNJ21827, DYNJ21828, DYNJ21839, DYNJ21886, DYNJ21965, DYNJ25096D,
DYNJ25104D, DYNJ25167B, DYNJ25222B, DYNJ25229C, DYNJ25235C, DYNJ25240A, DYNJ25243A,
DYNJ25270C, DYNJ25421A, DYNJ25458, DYNJ25461A, DYNJ25468C, DYNJ25538A, DYNJ25605B,
DYNJ25624B, DYNJ25645B, DYNJ25715, DYNJ25757B, DYNJ25792A, DYNJ25795, DYNJ25796A,
DYNJ25821A, DYNJ25825B, DYNJ25827A, DYNJ25829A, DYNJ25831B, DYNJ25891D, DYNJ25896B,
DYNJ25896B, DYNJ25908, DYNJ25925, DYNJ25929, DYNJ25935A, DYNJ25936A, DYNJ25941A,
DYNJ25957, DYNJ25987B, DYNJ26045A, DYNJ26045A, DYNJ26078A, DYNJ26100A, DYNJ26123A,
DYNJ26171C, DYNJ26172C, DYNJ26178A, DYNJ26181A, DYNJ26189, DYNJ26190A, DYNJ26191A,
DYNJ26192B, DYNJ26193B, DYNJ26196A, DYNJ26197, DYNJ26237A, DYNJ26241B, DYNJ26257B,
DYNJ26260A, DYNJ26277, DYNJ26278, DYNJ26289, DYNJ26294, DYNJ26294, DYNJ26325,
DYNJ26394A, DYNJ26420A, DYNJ26448, DYNJ26453A, DYNJ26455, DYNJ26459B, DYNJ26566,
DYNJ26570, DYNJ26573, DYNJ26608, DYNJ26635A, DYNJ26685, DYNJ26724A, DYNJ26726,
DYNJ26730, DYNJ26732, DYNJ26733A, DYNJ26750, DYNJ26753, DYNJ26757, DYNJ26761,
DYNJ26764, DYNJ26776, DYNJ26786B, DYNJ26848, DYNJ26848A, DYNJ26849A, DYNJ26850,
DYNJ26852, DYNJ26853, DYNJ26873, DYNJ26891, DYNJ26901, DYNJ26901A, DYNJ26922,
DYNJ26937, DYNJ26956A, DYNJ26964, DYNJ26964A, DYNJ26988, DYNJ26993, DYNJ27055,
DYNJ27073, DYNJ27088, DYNJ27110, DYNJ27154, DYNJ27154, DYNJ27160, DYNJ27165,
DYNJ27173, DYNJ27234, DYNJ27273, DYNJ27278, DYNJ27309, DYNJ27313, DYNJ27315,
DYNJ27337, DYNJ27412, DYNJ27438, DYNJC1028F, DYNJC1030G, DYNJC1131B, DYNJC1254J,
DYNJC1267F, DYNJC1361G, DYNJC1382D, DYNJC1517D, DYNJC1520C, DYNJC1541G, DYNJC1542C,
DYNJC1639G, DYNJC1657G, DYNJC1748B, DYNJC1753F, DYNJC1754A, DYNJC1834G, DYNJC1877A,
DYNJC1910F, DYNJC1912C, DYNJC1916B, DYNJC1981F, DYNJC1986N, DYNJC2023I, DYNJC2202N,
DYNJC2229L, DYNJC2237A, DYNJC2274G, DYNJC2281F, DYNJC2287B, DYNJC2288, DYNJC2338B,
DYNJC2373B, DYNJC2375B, DYNJC2393A, DYNJC2399A, DYNJC2413B, DYNJC2414B, DYNJC2418,
DYNJC2419G, DYNJC2420D, DYNJC2422B, DYNJC2427B, DYNJC2431G, DYNJC2431I, DYNJC2460A,
DYNJC2484C, DYNJC2485, DYNJC2588D, DYNJC2606G, DYNJC2684D, DYNJC2701A, DYNJC2714A,
DYNJC2715A, DYNJC2758J, DYNJC2759I, DYNJC2760I, DYNJC2762J, DYNJC2763G, DYNJC2764G,
DYNJC2766G, DYNJC2767I, DYNJC2768N, DYNJC2769I, DYNJC2794B, DYNJC2821, DYNJC2848C,
DYNJC2915D, DYNJC2956D, DYNJC2985A, DYNJC2994D, DYNJC3091F, DYNJC3110C, DYNJC3117D,
DYNJC3118G, DYNJC3137A, DYNJC3143G, DYNJC3184D, DYNJC3186C, DYNJC3187C, DYNJC3188D,
DYNJC3191C, DYNJC3225C, DYNJC3256A, DYNJC3259B, DYNJC3276, DYNJC3279C, DYNJC3280B,
DYNJC3292C, DYNJC3294A, DYNJC3299A, DYNJC3304A, DYNJC3349C, DYNJC3360A, DYNJC3362A,
DYNJC3367C, DYNJC3380A, DYNJC3417, DYNJC3418, DYNJH1054I, DYNJH1060B, DYNJH1158A,
DYNJH1223C, DYNJH1227A, DYNJH1235F, DYNJH1236, DYNJHS0116F, DYNJHS0145A, DYNJHS0181C,
DYNJHS0570, DYNJHS0597A, DYNJHS0597B, DYNJHS0604C, DYNJHS0605C, DYNJHS0628,
DYNJHS0709B, DYNJQ0009A, DYNJQ0020A, DYNJQ0029D, DYNJQ0043, DYNJQ0059F, DYNJQ0060B,
DYNJQ0063B, DYNJQ0064F, DYNJQ0097A, DYNJQ0100A, DYNJQ0114, DYNJQ0118B, DYNJQ0119B,
DYNJQ0120A, DYNJQ0123A, DYNJQ0124B, DYNJQ0127, DYNJQ0128A, DYNJQ0131A, DYNJQ0140C,
DYNJQ0157D, DYNJQ0162B, DYNJQ0171A, DYNJQ0172, DYNJQ0177A, DYNJQ0178C, DYNJQ0180B,
DYNJQ0185A, DYNJQ0191F, DYNJQ0207, DYNJQ0221, DYNJQ0226C, DYNJQ0227B, DYNJQ0234A,
DYNJQ0235A, DYNJQ0237A, DYNJQ0240A, DYNJQ0242A, DYNJQ0244B, DYNJQ0271, DYNJQ0286D,
DYNJQ0299A, DYNJQ0301A, DYNJQ0304A, DYNJQ0306B, DYNJQ0308B, DYNJQ0320A, DYNJQ0338A,
DYNJQ0365A, DYNJQ0369A, DYNJQ0370A, DYNJQ0376B, DYNJQ0405A, DYNJQ0411A, DYNJQ0415,
DYNJQ0439B, DYNJQ0461A, DYNJQ0486, DYNJQ0497, DYNJQ0508, DYNJQ0526, DYNJQ0529,
DYNJQ0541A, DYNJQ0543, DYNJQ0564, DYNJQ0567, DYNJQ0578, DYNJQ0584, DYNJSB0013,
DYNJT0017G, DYNJT0018I, DYNJT0019I, DYNJT0055B, DYNJT0056A, DYNJT0087B, DYNJT0162D,
DYNJT0225C, DYNJT0258A, DYNJT0483A, DYNJT0505B, DYNJT0507F, DYNJT0616B, DYNJT0617A,
DYNJT0627G, DYNJT1076G, DYNJT1077J, DYNJT1081G, DYNJT1083F, DYNJT1084B, DYNJT1085G,
DYNJT1107B, DYNJT1185C, DYNJT1187F, DYNJT1259B, DYNJT1273, DYNJT1282B, DYNJT1299B,
DYNJT1302B, DYNJT1416F, DYNJT1459, DYNJT1485B, DYNJT1589A, DYNJT1678A, DYNJT1679C,
DYNJT1695A, DYNJT1745F, DYNJT1759B, DYNJT1877B, DYNJT1878, DYNJT1901C, DYNJT1926B,
DYNJT1927A, DYNJT1936, DYNJT1938, DYNJT1943A, DYNJT1945A, DYNJT1947, DYNJT1972D,
DYNJT2003, DYNJT2014C, DYNJT2110B, DYNJT2119A, DYNJT2121B, DYNJT2144A, DYNJT2159C,
DYNJT2179, DYNJT2180D, DYNJT2185A, DYNJT2248A, DYNJT2262, DYNJT2388A, DYNJT2432A,
DYNJT2444, DYNJT2445, DYNJT2484C, DYNJV0039F, DYNJV0067I, DYNJV0069C, DYNJV0071G,
DYNJV0073C, DYNJV0076A, DYNJV0078C, DYNJV0079D, DYNJV0083C, DYNJV0098B, DYNJV0100D,
DYNJV0107F, DYNJV0160C, DYNJV0196B, DYNJV0218, DYNJY0001A, DYNJY0003A, DYNJY0010,
DYNJY0019B, DYNJY0041B, DYNJY0042A, DYNJY0050B, DYNJY0056B, DYNJY0057C, DYNJY0059B,
DYNJY0060C, DYNJY0064D, DYNJY0067C, DYNJY0069, DYNJY0074B, DYNJY0075A, DYNJY0080A,
DYNJY0083B, DYNJY0085A, DYNJY0090, DYNJY0097A, DYNJY0098A, DYNJY0102A, DYNJY0110B,
DYNJY0112A, DYNJY0118B, DYNJY0119, DYNJY0121, DYNJY0130A, DYNJY0131A, DYNJY0135,
DYNJY0141A, DYNJY0144, DYNJY0150A, DYNJY0151A, DYNJY0152A, DYNJY0153, DYNJY0162B,
DYNJY0166A, DYNJY0167A, DYNJY0168, DYNJY0169, DYNJY0173B, DYNJY0179B, DYNJY0181B,
DYNJY0183B, DYNJY0184B, DYNJY0186A, DYNJY0195A, DYNJY0203C, DYNJY0207B, DYNJY0210,
DYNJY0216, DYNJY0217A, DYNJY0218A, DYNJY0220, DYNJY0221, DYNJY0222, DYNJY0225,
DYNJY0227, DYNJY0228, DYNJY0236, DYNJY0238A, DYNJY0239, DYNJY0240, DYNJY0241,
DYNJY0244B, DYNJY0246, DYNJY0247, DYNJY0254A, DYNJY0276, DYNJY0277.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Waukegan, IL
REASON
There is a potential for open side seals post-sterilization of the Tyvek breather
pouches used in the custom sterile packs.
VOLUME OF PRODUCT IN COMMERCE
31,497 cases.
DISTRIBUTION
Nationwide.
PRODUCT
Cold Therapy Blanket.
CODE
Item No. T230ST Codes: 2797009, 3030109, 3403577;
Item No. T330ST Codes: 2930674, 3030125, 3058048, 3138849, 3139008, 3153547,
3316254, 3373996, 3432079, 3754300, 3754300;
Item No. T332ST Codes: 2031177, 2031185, 2797041, 3007785, 3010351, 3086698,
3088511, 3139024, 3213845, 3223980, 3316262, 3355991, 3410312, 3454500, 3531421,
3632046, 3678554;
Item No. T332VQ Codes: 3138857, 3139032, 3357700, 3521805, 3531448;
Item No. T333ST Codes: 3018628, 3088520, 3155999, 3239471, 3285419, 3356002,
3403614, 3632054, 3670211;
Item No. T333VQ Codes: 2920450, 3030168, 3315631, 3440255, 3592970, 3614315;
Item No. T350VQ Codes: 2847395, 3207429, 3315649, 3592988, 3613574;
Item No. T5030ST Codes: 2930578, 3029950, 3043014, 3239244, 3282728, 3355894,
3403518;
Item No. T5030ST-10 Code: 3678431;
Item No. T5031ST Codes: 3057791, 3138902, 3153512, 3239287, 3284491, 3316060,
3373793, 3431990, 3451771, 3505961, 3545436, 3580557, 3631941, 3647871, 3659901,
3668698, 3713647;
Item No. T5031ST-10 Codes: 3315622, 3329776;
Item No. T5032ST Codes: 2852864, 2975696, 3088431, 3316107, 3373831, 3401951,
3410208, 3451780, 3531392, 3580581, 3678458;
Item No. T5032ST-10 Codes: 2796891, 3009115, 3086680, 3194293, 3207402, 3223947,
3373849, 3631991
Item No. T5032VQ Codes: 2796903, 2975717, 3138937, 3239332, 3316115, 3373857,
3432028, 3531405, 3580590, 3647918;
Item No. T5033ST Codes: 2904636, 2975750, 3153539, 3194314, 3239359, 3316131,
3355923, 3373873, 3432036, 3449022, 3451798, 3647926, 3698598;
Item No. T5033ST-10 Codes: 3030037, 3088458, 3088466, 3239367, 3285355, 3355931,
3403542, 3454462, 3521813, 3532900, 3596436, 3632003;
Item No. T5033VQ Codes: 2678801, 3239375, 3316140, 3401969, 3505995, 3531413,
3580602, 3647977;
Item No. T5040ST Codes: 2181491, 2320147, 2371278, 2430477, 2496871, 2678819,
2904644, 2994521, 3030045, 3088491, 3138953, 3194541, 3239383, 3254495, 3285363,
3440221, 3592937, 3632011, 3678466;
Item No. T5050ST Codes: 2736169, 2753701, 2796954, 2897325, 2975805, 3030053,
3057900, 3194322, 3239404, 3316174, 3449031, 3451827, 3506040, 3713663;
Item No. T5050ST-10 Codes: 1909831, 2975821, 3057942, 3316182;
Item No. T5050VQ Codes: 2678827, 2796971, 3057951, 3316191, 3647993;
Item No. T5090ST Codes: 2812011, 289725;
Item No. T530ST Codes: 2930682, 3030176, 3058072, 3402048; Item No. T531ST Code:
3402081;
Item No. T533ST Codes: 2753831, 3088554, 3402128;
Item No. T540ST Code: 2215216;
Item No. T590ST Codes: 1910081, 2320059, 2326485.
RECALLING FIRM/MANUFACTURER
DeRoyal Technologies, Inc., New Tazewell, TN
REASON
There is a possibility of water leaking from the welded seam of the blanket.
VOLUME OF PRODUCT IN COMMERCE
5,084 units.
DISTRIBUTION
Nationwide and Mexico.
PRODUCT
Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System.
CODE
Serial numbers: 8, 960, 1341, 1343, 1344, 1351 through 1354, 1359, 1363, 1365
through 1368, 1372, 1379, 1581, 1583, 1584, 1589 through 1593, 1598, 1599, 1756,
1757, 1760, 1771, 1784, 1786, 1792, 1793, 2001, 2005, 2007, 2012 through 2018,
2020 through 2025, 2028, 2029, 2031, 2032, 2036, 2037, 2038, 2041, 2043, 2044,
2047, 2175, 2176, 2177, 2180 through 2187, 2189 through 2195, 2197, 2198, 2348,
2355 through 2370, 2372, 2373, 2374, 2375, 2376, 2378, 2381, 2382, 2389, 2390,
2392, 2393, 2400 through 2433, 2435, 2436, 2442, 2443, 2453, 2475, 2560, 2562,
2563, 2564, 2565, 2566, 2568, 2569, 2572 through 2579, 2590, 2592, 2593, 2595,
2596, 2597, 2598, and 2599.
RECALLING FIRM/MANUFACTURER
Sybaritic, Inc., Bloomington, MN
REASON
Device is performing functions that are not cleared in the 510(k).
VOLUME OF PRODUCT IN COMMERCE
152 units.
DISTRIBUTION
Nationwide and the Phillipines.
PRODUCT
PepGen P-15 Putty(0.5cc). Article Number: 99U200-005.
CODE
Lot Number:04P1017A.
RECALLING FIRM/MANUFACTURER
Dentsply Friadent Ceramed, Lakewood, CO
REASON
PepGen P-15 Putty kit was labeled with the incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
250 kits.
DISTRIBUTION
Nationwide, Canada, and British Columbia.
PRODUCT
KinAir MedSurg, flotation therapy, powered hospital bed.
CODE
Serial Numbers KASK00001 through KASK01212.
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX
REASON
Weld failure causes side rail welds to turn upside down or break off of the
bed.
VOLUME OF PRODUCT IN COMMERCE
1,181 beds.
DISTRIBUTION
Nationwide and Brazil.
PRODUCT
a) BD Nexiva Closed IV Catheter System, 18 gauge.
Catalog Numbers: 383508, 383509.
b) BD Nexiva Closed IV Catheter System, 20 gauge.
Catalog Numbers: 383505, 383506, 383507.
c) BD Nexiva Closed IV Catheter System, 22 gauge.
Catalog Number: 383502.
d) BD Nexiva Closed IV Catheter System, 24 gauge.
Catalog Numbers: 383500, 383501.
CODE
All Lot numbers.
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT
REASON
The Y-luer connection may crack during normal product use.
VOLUME OF PRODUCT IN COMMERCE
4,795 catheters.
DISTRIBUTION
IL, UT, TX, and FL.
PRODUCT
a) The product is a battery operated toothbrush.
Spinbrush Pro Whitening Ex Soft battery operated
toothbrushes UPC 76687800191.
b) The product is a battery operated toothbrush.
Spinbrush Pro Whitening Medium battery operated
toothbrushes UPC 76687800193.
c) The product is refill heads for battery powered
toothbrushes. Spinbrush Pro Whitening EX Soft
Refill Heads, UPC776687800192.
d) The product is refill heads for battery powered
toothbrushes. Spinbrush Pro Whitening Medium
Refill Heads, UPC776687800194.
e) The product is a Spinbrush Pro EX Soft battery
operated toothbrushes. UPC 76687800078.
f) The product is a Spinbrush Pro Medium battery
operated toothbrushes. UPC 76687800079.
g) The product is a Spinbrush Pro EX Soft battery
powered Refill heads for battery powered
toothbrushes. UPC 776687800080.
h) The product is refill heads for battery powered
toothbrushes. Spinbrush Pro Medium Refill heads,
UPC 776687800081.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Proctor & Gamble CO., Cincinnati, OH
REASON
The brushes may experience head breakage when insufficiently rinsed after use
and when used in combination with toothpastes containing a combination baking
soda, peroxide, and sodium lauroyl sarcosinate.
VOLUME OF PRODUCT IN COMMERCE
15 million toothbrushes and refill heads.
DISTRIBUTION
Nationwide, Guam, Puerto Rico, and Aruba.
PRODUCT
a) Medtronic Marquis VR, model 7230 Single Chamber
Implantable Cardioverter Defibrillator (ICD)
devices are tiered therapy implantable arrhythmia
control devices, which provide automatic detection
of ventricular arrhythmias and delivery of user-
selected therapies for the detected arrhythmia.
Therapies are automatically delivered following
detection or can be initiated via programming by the
physician. These ICDs are multi-programmable and have
the capability of transmitting via telemetry the
programmed values, measured and collected data, and
event markers.
b) Medtronic Maximo VR, model 7232 Single Chamber
Implantable Cardioverter Defibrillator (ICD).
c) Medtronic Marquis DR, model 7274 Dual Chamber
Implantable Cardioverter Defibrillator (ICD).
d) Medtronic InSync Marquis, model 7277 Dual Chamber
Implantable Cardioverter Defibrillator (ICD) with
Cardiac Resynchronization Therapy.
e) Medtronic Maximo DR, model 7278 Single Chamber
Implantable Cardioverter Defibrillator (ICD).
f) Medtronic InSync III Marquis, model 7279 Dual
Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy.
g) Medtronic InSync III Protect, model 7285 Dual
Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy.
h) Medtronic InSync II Marquis, model 7289 Dual
Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy.
CODE
a) (Serial numbers listed include all affected
devices but may include some unaffected devices.
Patients are recommended to check with their
doctor for exact serial numbers affected.)
7230B S-Series: PLW600001S - PLW600646S.
7230Cx H-Series: PKD100001H - PKD116584H,
PKD117397H, PKD117553H, PKD117735H, and PKD117741H.
R-Series: PKD200084R - PKD200536R, PKD600016R --
PKD600113R. S-Series: PKD600009S - PKD608391S.
7230E S-Series: PLY600001S - PLY600749S and
PLY600839S.
b) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series:
PRN800001A - PRN800024Q. S-series PRN600001S --
PRN602430S and PRN604401S - PRN604831S;
c) (Serial numbers listed include all afffected
devices but may include some unaffected devices.
Patients are recommended to check with their
doctor for exact serial numbers affected.)
H-Series: PKC100001H - PKC138887H and PKC142234H.
R-series: PKC200320R - PKC200572R.
A-Series: PKC120001S - PKC120092S and PKC600001S --
PKC617090S.
d) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) H-Series: PLT100002H --
PLT100583H. S-Series: PLT600001S - PLT611901S;
e) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series: PRM800001Q --
PRM800123Q. S-Series: PRM600001S - PRM605919S and
PRM606025S - PRM606035S;
f) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series: PLU400002Q --
PLU400172Q and PLU800002Q - PLU800878Q.
S-Series: PLU600001S - PLU602739S and PLU800001S --
PLU800085S;
g) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for exact
serial numbers affected.) Q-Series: PPC800001Q --
PP800011Q. H-Series: PPC100002H - PPC100005H.
S-Series: PPC600001S - PPC600184S.
h) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) S-Series: PRJ600001 --
PRJ609639S and PRJ614813 - PRJ614815S.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm Management, Fridley, MN
REASON
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured
prior to December 2003 that may experience rapid battery depletion due to a
specific internal battery short mechanism. Once a short occurs, depletion can
take place within a few hours to a few days, after which there is a complete
loss of device function.
VOLUME OF PRODUCT IN COMMERCE
100,288 devices.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Roche brand ISE SnapPak for use only in the AVL
9120/9130 Electrolyte Analyzer. Ref/No. 03112276180;
Part number BP5016.
b) Roche brand ISE SnapPak for use only in the AVL
9180/9181 Electrolyte Analyzer; Ref/No. 03112349180,
Part number BP5186.
c) Roche brand ISE SnapPak for use only in the AVL
9110/9140 Electrolyte Analyzer; Ref/No. 03112314018,
Part number BP5032.
d) Bayer brand Technicon RA/opeRA Systems ISE Fluid
Pack for in vitro diagnostic use on the opera
system only, Manufacturer part number T01-3606-01,
Roche part number 03361322001.
e) Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid
Pack for use in the STARLYTE III electrolyte analyzer,
Roche part number 03361152001.
f) AVL Scientific Corp. brand 9180 SnapPak Type D,
BP5206, for use only in the AVL 9180 electrolyte
analyzer, Roche part number 03112357182.
g) Vital Scientific brand ISE Snap Pack for use only
in the ISE Module 9130, Ref no. 3203-007, Roche part
number 03522032001.
CODE
a), b), c), d), e) All units;
f) All units. (Sold only outside of the U.S.
by Sysmex in Japan.);
g) All units. (Sold only outside of the U.S.
by Vital in Netherlands).
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN
REASON
A defective seam in the two chamber pouch may result in the mixing of reagents,
which would either result in an inability to calibrate the analyzer or would
bias patient results.
VOLUME OF PRODUCT IN COMMERCE
137,037 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) CryoValve, Pulmonary Valve & Conduit. Donor #62654,
Model #PV00.
b) CryoValve, Aortic Valve and Conduit. Donor #62654,
Model #AV00.
CODE
a) Serial #7816169;
b) Serial #7816174.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON
Records noted that the infant donor's mother had tested positive for Hepatitis
B.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CA, and FL.
PRODUCT
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized,
single use device inserted into the patient's trachea via the mouth to maintain
an open airway; Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm).
CODE
Lot 1152181, Exp 10-2009.
RECALLING FIRM/MANUFACTURER
Teleflex Medical, Bannockburn, IL
REASON
Some of the primary labels have the internal diameter (ID) and outer diameter
(OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID
8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
VOLUME OF PRODUCT IN COMMERCE
8,990 units.
DISTRIBUTION
Nationwide.
PRODUCT
Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized
with ethylene oxide gas. For single use only. Catalog number 4038553S.
CODE
Lot # L0104244.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL
REASON
The product is labeled as Straight Catheter but the package contains Contralateral
Guide shaped Catheters.
VOLUME OF PRODUCT IN COMMERCE
40.
DISTRIBUTION
FL, OK, SC, and KS, South Africa and the Netherlands.
HeartSine Technologies, Inc., San Clemente, California, is initiating a worldwide recall of some samaritan® Automatic External Defibrillators (AEDs). This recall affects HeartSine samaritan® AED models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. These devices may in some cases shut down before delivering a shock, which could result in a delay in treatment or death of a viable patient. This recall was initiated after receipt of several user complaints of shut-down during an attempted charge. HeartSine Technologies, Inc. believes that some of the affected devices could exhibit longer than usual charging rates, causing an alarm and shutdown of the device as mentioned above.
HeartSine Technologies, Inc. initiated notification of its distributors and customers by letter on February 14, 2005, and is providing a user-installable field software upgrade for all affected AEDs. Distributors and customers who have HeartSine samaritan® AEDs within this serial number range, who have not yet received an upgrade kit, should contact the manufacturer to determine if their product(s) are affected, and if so, arrange to obtain a field upgrade kit as soon as possible.
Six hundred seventy-two (672) of the affected HeartSine samaritan® AEDs were distributed, with five hundred thirty-two (532) within U.S. and U.S. Territories. The products can be identified by the words “samaritan® AED” on the front of the device. Please note that the HeartSine samaritan® PAD automatic external defibrillator (Model SAM-300) is NOT subject to this action.
Consumers with questions may contact the company at 1-949-218-0092 or 1-866-478-7463.
WEEK ENDING MARCH 26
PRODUCT
a) Angiographic Syringe, 10 cc Thumb Ring
with Rotator Reservoir.
b) Angiographic Syringe, 12 cc Thumb Ring
with Rotator Reservoir. ;
c) Angiographic Syringe, 12 cc Thumb Ring
with Rotator Non-Reservoir.
d) Angiographic Syringe, 12 cc Palm Pad with
Rotator Reservoir.
e) Catheterization Kits containing Angiographic
Syringes with Rotator Connector.
CODE
a) List Numbers: 4204004 Lot Numbers: 15173SN, 19104SN;
b) List Numbers: 4204201 Lot Numbers: 13193SN, 15171SN;
17151SN;
c) List Numbers: 4204401 Lot Numbers: 17149SN;
d) List Numbers: 4204801 Lot Numbers: 14182SN;
e) List Numbers: 460690403; 460690469; 460710409;
460710468; 460730411; 460730412; 460730414;
460730455; 460730470; 460730472; 460750442;
460750461; 460780417; 460780453; 460790418;
460830405; 460830411; 460830431; 460830470;
460830471; 460830473; 460840444; 460840454;
460840463; 460840475; 460870444; 460870455;
460870464; 460870467; 460870471; 460880477;
460890413; 460890419; 460890456; 460890461;
460890465; 460890471; 460890478; 460900407;
460900420; 460900465; 460900473; 460920412;
460920422; 460920431; 460920454; 460920455;
460920470; 460930404; 460930418; 460930419;
460930426; 460930468; 460930478; 460950404;
460950405; 460950417; 460950426; 460950429;
460950433; 460950436; 460950437; 460950439;
460950443; 460950444. Lot Numbers: 09284SN;
10004SN; 10019SN; 10026SN; 10042SN; 11007SN;
10008SN; 11081SN; 11085SN; 11122SN; 11182SN;
11225SN; 11228SN; 11245SN; 11272SN; 11295SN;
11313SN; 12022SN; 12039SN; 12074SN; 12075SN;
12091SN; 12116SN; 12128SN; 12131SN; 12250SN;
12253SN; 12281SN; 12282SN; 12284SN; 13016SN;
13033SN; 13060SN; 13096SN; 13123SN; 13189SN;
13193SN; 13271SN; 13275SN; 13283SN; 13285SN;
13292SN; 13294SN; 13296SN; 14018SN; 14107SN;
14128SN; 14129SN; 14141SN; 14144SN; 14182SN;
14232SN; 14236SN; 14242SN; 14249SN; 14269SN;
14298SN; 14302SN; 14306SN; 14309SN; 15020SN;
15036SN; 15061SN; 15123SN; 15126SN; 15149SN;
14161SN; 15162SN; 15163SN; 15164SN; 15171SN;
15173SN; 15224SN; 15241SN; 15245SN; 15250SN;
15253SN; 15257SN; 16007SN; 16013SN; 16032SN;
16045SN; 16052SN; 16084SN; 16088SN; 16137SN;
16213SN; 16227SN; 16235SN; 16273SN; 16274SN;
16279SN; 16287SN; 17019SN; 17084SN; 17086SN;
17105SN; 17106SN; 17116SN; 17133SN; 17149SN;
17151SN; 17204SN; 17211SN; 17220SN; 18004SN;
18008SN; 18021SN; 18022SN; 18045SN; 18055SN;
18066SN; 18116SN; 18118SN; 18127SN; 18128SN;
18134SN; 18147SN; 18156SN; 18161SN; 18239SN;
18249SN; 18250SN; 18284SN; 18290SN; 19010SN;
19074SN; 19090SN; 19104SN; 19156SN; 19182SN;
20024SN; 20064SN; 20065SN; 20067SN; 20069SN;
20073SN; 20082SN; 20085SN; 20171SN; 20174SN;
20224SN; 20225SN; 21137SN; 21209SN; 21218SN;
22213SN.
RECALLING FIRM/MANUFACTURER Hospira, Inc., Lake Forest, IL
REASON
Syringes could possibly allow air to enter the patient's vascular system.
VOLUME OF PRODUCT IN COMMERCE
72,555 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) MurphyScope, Bayonet, Malleable,
Catalog # 2121-157.
b) MurphyScope, Curved, Malleable,
Catalog # 2125-163.
CODE
a) Lot A52300;
b) Lot A57384.
RECALLING FIRM/MANUFACTURER
Medtronic Neurosurgery, Goleta, CA
REASON
Products are mislabeled. Each designated lot contains the other model. Bayonet
type contains Curved and vice versa.
VOLUME OF PRODUCT IN COMMERCE
4 devices.
DISTRIBUTION
NJ and India.
PRODUCT
a) LICOX Complete Brain IMC Probe Kit,
Model IM3.ST C.
b) LICOX temperature probe, Model C8.B.
CODE
a) Lot numbers: 2506, 3904, 04779, 04795,
04835, 14716, 18141, 19059, 21044, 28800,
28806, 28806A, 47814, 050105, 619202,
619406, 619419, 619466, 619536, 619593,
619632, 619675, 619733, 619886, 619999,
620331/1;
b) Lot numbers: 160504 and 240604.
RECALLING FIRM/MANUFACTURER
Integra Neuro Sciences, San Diego, CA
REASON
LICOX Model C8.B temperature probes may exhibit progen (endotoxin) levels above
the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels
may result in an increased patient risk of fever.
VOLUME OF PRODUCT IN COMMERCE
842 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360),
catalog number 66009585 Dental impression material.
b) Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy+Light, catalog number 66009583.
c) Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360),
catalog number 66009584.
d) Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase, catalog number 66009582.
CODE
a) Lots 190429,190438, 190519, 190521, 190522,
190524, 190535, 190545, 190547, 190554 and 190560;
b) Lots 195402, 195404, 195405, 195411, 195412
and 195420;
c) Lot 190416;
d) Lots 195417 and 195418.
RECALLING FIRM/MANUFACTURER
Heraeus Kulzer Inc., South Bend, IN
REASON
Packaging defects could result in improper mixing ratios and unusable impressions.
VOLUME OF PRODUCT IN COMMERCE
2,672 bags.
DISTRIBUTION
Nationwide.
FDA Asks U.S. Marshals to Seize Adulterated and Misbranded Hospital Bed Systems
In a response to ongoing concerns about manufacturing quality and labeling, the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of all finished Vail 500, 1000, and 2000 Enclosed Bed Systems made by Vail Products, Inc., located in Toledo, OH. Use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death.
FDA advises consumers to stop using Vail 500, 1000 and 2000 Enclosed Bed Systems until they receive additional instructions from Vail Products.
The U.S. Marshal’s Office also seized welded in-process components and all labeling and promotional materials for the Vail 500, 1000, and 2000 products.
FDA believes the Vail products seized today do not meet with the Quality System regulations of the Federal Food, Drug and Cosmetic Act and pose significant health risk for consumers.
The Enclosed Bed Systems are misbranded because they are dangerous to health when used in the manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling. They are further misbranded because they lack adequate directions for use and adequate warnings, thereby placing patients at an increased risk of entrapment and asphyxiation.
Additionally, Vail Products failed or refused to furnish material or information to the FDA as required by Medical Device Reporting regulation and the Reports of Corrections and Removals regulation.
FDA inspections of Vail Products, Inc., revealed that the firm has continually failed to follow the requirements of the Quality System regulation when manufacturing enclosed bed systems. Vail Products has previously received two FDA Warning Letters outlining unacceptable practices. The firm was given an opportunity to correct the violations, but failed to take appropriate actions.
Nationwide Alert On B-Sure Pregnancy Test
Harmony Brands, Oak Park, Michigan, a national distributor of health, cosmetic and other consumer products, is voluntarily recalling its B-Sure brand One-Step Home Pregnancy Test., because its safety and efficacy can no longer be assured.
Consumers who have unused & unexpired B-Sure brand One-Step Home Pregnancy Test in their possession should not use the product and should return the product to the point of purchase for a refund. Additionally, women who have used the test may wish to contact their health care provider to verify the test results.
The tests which are the subject of the recall were sold throughout the United States in a variety of retail outlets, including Dollar Stores and convenience stores. The tests can be identified by the product label notation “B-sure” pregnancy test. Additional information identifying the product can be found on the Harmony Brands website at www.harmonybrands.com.