MARCH 2004
WEEK ENDING MARCH 6
PRODUCT CO2 Laser coding/marking
machine. Solar Jet:e-SolarMark Laser.
CODE None.
RECALLING FIRM/MANUFACTURER Weber Marking Systems, Arlington Heights,
IL.
REASON Labels missing.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION IL.
PRODUCT Quattro FAP System, Class IV multi-wavelength laser diode
material processing machine.
CODE None.
RECALLING FIRM/MANUFACTURER Coherent, Inc, Santa Clara, CA.
REASON Performance requirement-safety interlocks malfunction due to
improper information included in the software operating the laser
VOLUME OF PRODUCT IN COMMERCE 52 units.
DISTRIBUTION Nationwide.
PRODUCT Magnivision UltraLights reading glasses which have the dioptic
power on the label and "Magnivision and American Greetings Co.
CODE Product is not coded. All product on the market at the time the
recall is initiated.
RECALLING FIRM/MANUFACTURER Magnivision, Inc., Miramar, FL.
REASON Possibility of eye injury from large tags on promotional sale
product when customer tries them on in store.
VOLUME OF PRODUCT IN COMMERCE 145,884.
DISTRIBUTION FL.
PRODUCT 18 Gauge thin wall needle as part of a Central Venous Catheter
Kit.
CODE List No. 414000413, Lot No. 02053SN, 02062SN, 03307SN, 04064SN,
05248SN, 05308SN, 06248SN, 93297SN, 96294SN.
List No. 414000415, Lot No. 04240SN, 04241SN.
List No. 414010423, Lot No. 02057SN, 02065SN, 03257SN, 04238SN, 05341SN,
06249SN, 93208SN, 94194SN, 95224SN, 96054SN.
List No. 414010425, Lot No. 02051SN, 02058SN.
List No. 414050415, Lot No. 04239SN, 06244SN, 07244SN, 95221SN.
List No. 414060423, Lot No. 02059SN, 03261SN, 06245SN, 93206SN, 95220SN,
95232SN.
List No. 414070423, Lot No. 02354SN, 03258SN, 95222SN.
List No. 414110423, Lot No. 02052SN, 03259SN, 05342SN, 07250SN, 93296SN,
94196SN, 95233SN.
List No. 414110425, Lot No. 02049SAN, 03260SAN, 93207SN.
List
No. 414130415, Lot No. 02050SN, 04065SN, 05249SN, 95223SN, 95229SN.
List No. 414140423, Lot No. 02061SN, 04063SN, 06247SN, 94195SN, 95231SN,
96056SN.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott
Park, IL.
REASON 18 gauge needles in Central Venous Catheter kits may be partially
occluded.
VOLUME OF PRODUCT IN COMMERCE 93,564.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers:
46-701, 46-702, 46-703, 46-704,
46-702-1,
46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box.
CODE Affected Lot Numbers: 66430, 68064, 89375, 93956, 103552, 110015,
106770, 346423, 354811, 387794, 492877, 492906.
RECALLING FIRM/MANUFACTURER DeRoyal Surgical Tray, New Tazewell, TN.
REASON Hydrophilic powder wound dressing, sterilized at a dosage which
subsequently failed a sterility audit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2,495 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Nitrate Reagent A, Cat No. Z71; Nitrate Reagent B, Cat. No. A72.
CODE Lot 3338.
RECALLING FIRM/MANUFACTURER Hardy Media Inc., Dba Hardy Diag., Santa
Maria, CA.
REASON Mislabeled.
VOLUME OF PRODUCT IN COMMERCE 39 bottles of Z71 and 6 bottles of Z72.
DISTRIBUTION TX, CA, ID, Puerto Rico, KS and WY.
The
Food and Drug Administration (FDA) today announced that Moving Solutions, Inc.,
of Downers Grove, Ill., is recalling its patient lifts because of a faulty
design.
Patient
lifts are mechanical sling-like devices used to lift and move patients from one
place to another, as from a bed to a bath. They are used in hospitals and
nursing homes in the care of elderly and handicapped persons. Some may also be
used in homes.
With
the Moving Solutions lift, excessive wear of the main bolt, which secures the
lift arm to the main frame of the patient lift, will cause the bolt to break.
When the bolt breaks, the lift arm is no longer secured to the lift, which will
cause the patient to fall. The lift arm may also fall on the patient, which
could result in serious injury, even death.
Facilities
should stop using these lifts until the problem is corrected.
The
recall involves all FAABORG model battery operated patient lifts distributed by
Moving Solutions, because the lift arm is interchangeable between all models of
FAABORG patient lifts. Some 856 lifts have been distributed throughout the
United States.
FAABORG,
located in Denmark, is the manufacturer. Moving Solutions is the initial U.S.
distributor; however there may be some other distributors.
Moving
Solutions notified user facilities of a problem with the device in November
2001. In a letter, they directed facilities to perform maintenance and check
the hanger bar bolt for any signs of wear.
The
firm again notified user facilities on Jan. 21, 2004 about a continuing problem
with the bolt and included a nylon washer with their letter, instructing
facilities to insert the washer between the hanger bar bolt and the sling
spreader arm. The FDA has no assurance that the washer will prevent the rubbing
that caused the bolt to wear and break, and an investigation is underway.
FDA
is monitoring the firm's action to make sure that all facilities which use
these lifts are adequately notified of the problem and to make sure that no
more products are distributed.
WEEK ENDING MARCH 13
PRODUCT
a) General Electric Seneographe 2000D Digital Mammography X-Ray System.
b) General Electric Seneographe DMR Mammography X-Ray System (all
versions).
c) General Electric Seneographe 700T Mammography X-Ray System.
d) General Electric Seneographe 800T Mammography X-Ray System.
e) General Electric Seneographe 500 Mammography X-Ray Systems (all
versions).
f) General Electric Seneographe 600 Mammography X-Ray Systems (all
versions).
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER General Electric Med Systems, Waukesha, WI.
REASON The mammography system's information for users lacked the
technical specification for the minimum filtration permanently installed in the
useful beam and the technical specification for the maximum line current.
VOLUME OF PRODUCT IN COMMERCE 6,931 units.
DISTRIBUTION Nationwide.
PRODUCT Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5
units are a later version of the AS/3 units. The conversion from AS3 to S5
occurred during the summer of 2000. This change was mainly a product name
change, with a slight color variation to the shade of white being used
externally on the machine. There were no design or feature and function
modifications when the name change occurred.)
CODE Serial numbers between 40013635 and 40162379.
RECALLING FIRM/MANUFACTURER Datex-Ohmeda, Inc., Madison, WI.
REASON Anesthetic agents could be delivered at concentrations above the
concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having
serial numbers within a specified range.
VOLUME OF PRODUCT IN COMMERCE 8,700 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT
Hem-o-Lok"SMX
Ligating Clip, REF 544220, Non-absorbable Polymer Ligation Clips, Sterile EO,
Single use, Disposable.
CODE Lot number 988384.
RECALLING FIRM/MANUFACTURER Weck, Research Triangle Park, NC.
REASON Malformation of the Hem-o-lok SMK clip.
VOLUME OF PRODUCT IN COMMERCE 70 sales units (containing 14 cartridges
with 4 clips on each cartridge).
DISTRIBUTION Nationwide, Korea and France.
PRODUCT CryoValve Pulmonary Valve and Conduit. Donor #29640, Model #PV00
(Pulmonary Valve).
CODE Serial #6194362.
RECALLING FIRM/MANUFACTURER CryoLife Inc., Kennesaw, GA.
REASON As part of this ongoing retrospective review, CryoLife has
identified a donor who does not meet current guidelines regarding serodilution
of plasma because of the amount of transfused/infused fluids administered.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT VACUTAINER Brand Push Button Blood Collection Sets.
CODE Batch #3218665.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Company, Franklin
Lakes, NJ.
REASON A hole was noticed in the blister pack that is used to package
the device and provides the sterility barrier. Sterility could be compromised.
VOLUME OF PRODUCT IN COMMERCE 4,400.
DISTRIBUTION CA, and VA.
PRODUCT
Clinical
Chemistry Urea Nitrogen.
CODE Lots: 05073HW00, 04022HW00, 03041HW00.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div, South
Pasadena, CA.
REASON
Low results
due to contaminant.
VOLUME OF PRODUCT IN COMMERCE 568.
DISTRIBUTION Nationwide and Internationally.
PRODUCT SCIPRO Flexible Stone Dislodger and Retrieval Set. Catalog
#SP3000146ST.
CODE Lot # OML30403-01.
RECALLING FIRM/MANUFACTURER Scion Cardio-Vascular, Inc., Miami, FL.
REASON Possible difficulty for the user in opening the stone retrieval
basket.
VOLUME OF PRODUCT IN COMMERCE 28.
DISTRIBUTION Nationwide.
PRODUCT
a) BE 183 Series Manual Jet Ventilator. Part #BE 183-SU.
b) BE 183 Series Manual Jet Ventilator with Regulator and Gauge. Part #BE
183-SU.
CODE
a) Lot number P0907203;
b) Lot number P0908103.
RECALLING FIRM/MANUFACTURER Instrumentation Industries, Inc., Bethel
Park, PA.
REASON Possible external debris in the on/off plunger.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION CA, FL, GA, NY, OH, OR, TX, and UT.
PRODUCT SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog #
SP3000146-ST used for removal of calculi, fragments of medical devices and
other foreign objects uring urological or gatroenterological procedures.
CODE Lot number OML30522-01.
RECALLING FIRM/MANUFACTURER Scion Cardio-Vascular, Inc., Miami, FL.
REASON The firm received field complaints that is was difficult to open
the stone retrieval basket during use.
VOLUME OF PRODUCT IN COMMERCE 41.
DISTRIBUTION IL, and AL.
PRODUCT
a) 2.5mm Hex Driver.
b) 4mm Hex Driver.
CODE
a) Lot #04160301, Catalog Number OP20004, Lot # O2F108, O2F109, O2G322, O2G323,
O2G324, O3E221,
Catalog Number SP00005-US;
b) Lot # 02190301, 05120311, Part # MU20012, Revision I.
RECALLING FIRM/MANUFACTURER U&I America, Murray, UT.
REASON Reports of hex driver tips breaking off or becoming worn or
stripped.
VOLUME OF PRODUCT IN COMMERCE 620 units.
DISTRIBUTION MN.
PRODUCT Crossfire Acetabular II Insert. Catalog No. 2041C-2642.
CODE Lot 48921601.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ.
REASON This device is not approved for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE 3 devices.
DISTRIBUTION MI.
PRODUCT
a) The device is in a tyvek pouch and is labeled in part: Aviator Peripheral
Dilatation Catheter REF Cat. No. Lot
No., Use By Method of Sterilization ETO Min. Guiding Catheter ID Nominal
Pressure Rated Burst Pressure.
b) The device is labeled as Sterile and is packaged in a Tyvek pouch with the
following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX
Delivery System REF Cat. No. Cordis NDOVASCULAR Lot No.,
CODE
a) New Lots with October 2003 or newer dating embedded in lot number
("1003" MMYY in the second to fifth digit of Lot Number) and any
older ones with a Green Dot indicating that they passed Cordis Inspection ARE
NOT COVERED. The following previsouly uninspected lots were covered under the
recall: AVIATOR ITEM_NO LOT_NO 4224015S R0103043 4224015S R0202421 4224015S
R0403032 4224015S R0603169 4224015S R0902952 4224015S R1102231 4224015S
S0602108 4224015X R0303535 4224015X R0402115 4224015X R0603722 4224015X
R0902953 4224015X R1002434 4224015X S0502104 4224020S R0102364 4224020S R0102920
4224020S R0103968 4224020S R0202151 4224020S R0202862 4224020S R0203105
4224020S R0203499 4224020S R0302900 4224020S R0502712 4224020S R0503318
4224020S R0602462 4224020S R0702480 4224020S R0802055 4224020S R0802263
4224020S R0802850 4224020S R0802863 4224020S R1002174 4224020S S0102054
4224020S S0102686 4224020S S0202251 4224020S S0602109 4224020S S1002019
4224020S S1002209 4224020X R0103044 4224020X R0103196 4224020X R0103714
4224020X R0103969 4224020X R0202004 4224020X R0202206 4224020X R0203106 4224020X
R0302095 4224020X R0303719 4224020X R0603339 4224020X R0702481 4224020X
R0702652 4224020X R0702915 4224020X R0802056 4224020X R0802269 4224020X
R0902477 4224020X R1002935 4224020X R1102003
4224020X R1102019 4224020X S0102050 4224020X S0602110 4224020X S1002020
4224030S R0202207 4224030S S0102051 4224030X R0202209 4224030X R0303023
4224030X R0603480 4224030X R0703380 4224030X R0802270 4224030X R1002567
4224030X R1002681 4224030X S0102052 4224030X S0303012 4224040S R0202005
4224040S R0902705 4224040S S0202252 4224040X R0202210 4224040X R0203503
4224040X R0502606 4224040X R0603723 4224040X R0902562 4224040X R1202527
4224515S R0102923 4224515S R0303021 4224515S R0702656 4224515S R1002682
4224515X R0202422 4224515X R0303534 4224515X R0502832 4224520S R0302096
4224520S R0702482
4224520S S0302254 4224520X R0202423 4224520X R0202863 4224520X R0402641
4224520X R0502377 4224530X R0102922 4224530X R0302596 4224540X R0402885
4224540X S0602136 4225015S R0103045 4225015S R0103398 4225015S R0103971
4225015S R0802864 4225015S S0502035 4225015S S0802199 4225015X R0103474
4225015X R0302097 4225015X R0303202 4225015X R0703132 4225015X R0902478
4225015X R1102232 4225015X S0402079 4225015X S0502134 4225020S R0102365
4225020S R0102366 4225020S R0102663 4225020S R0102703 4225020S R0103046
4225020S R0103715 4225020S R0202152 4225020S R0202698 4225020S R0202864
4225020S R0203107
4225020S R0302328 4225020S R0503679 4225020S R0702978 4225020S R0802271
4225020S R0802851 4225020S R0802865 4225020S S0102001 4225020S S0102415 4225020S
S0802200 4225020X R0103475 4225020X R0103717 4225020X R0103970 4225020X
R0202446 4225020X R0203108 4225020X R0203505 4225020X R0402642 4225020X
R0403309 4225020X R0502092 4225020X R0503943 4225020X R0602336 4225020X
R0702688 4225020X R0702916 4225020X R0702977 4225020X R0802272 4225020X
R0802852 4225020X R0803122 4225020X R1002175 4225020X S0202007 4225020X
S0402218 4225020X S0502383 4225020X S0802201 4225030S R0202565 4225030S
S0502102
4225030X R0202566 4225030X S0202048 4225030X S0502103 4225040S R0302967
4225040S S0502135 4225040X R0103399 4225040X R0202699 4225040X R0403334
4225040X R0502378 4225040X R1002713 4225040X S0402219 4225515S R0202700
4225515S R0503714 4225515S S0802202 4225515X R0202788 4225515X R0303022
4225515X R0702689 4225515X R0802273 4225515X R1102020 4225520S R0202766
4225520S R0302647 4225520S R0602805 4225520X R0202767 4225520X R0302648
4225520X R0403033 4225520X R0602339 4225520X R0602812 4225520X S0502036
4225520X S0602137 4225530X R0402680 4225540X R0402116 4225540X R0403826 4226015S
R0202768
4226015S R0203748 4226015S R0403620 4226015S R0502500 4226015S R0603490
4226015S R0702508 4226015S R1102583 4226015S S0802203 4226015X R0302649
4226015X R0602863 4226015X R0603487 4226015X R0902216 4226015X R1102230
4226015X S0202253 4226015X S1002212 4226020S R0102367 4226020S R0102665
4226020S R0102704 4226020S R0202003 4226020S R0202153 4226020S R0702510
4226020S R0702976 4226020S R0802853 4226020S R0902707 4226020S S0102149
4226020S S0102171 4226020S S0102262 4226020S S0302289 4226020S S0802180
4226020X R0103718 4226020X R0202785 4226020X R0203110 4226020X R0402117
4226020X R0502093
4226020X R0503154 4226020X R0602006 4226020X R0603725 4226020X R0702511
4226020X R0702690 4226020X R0702917 4226020X R0702975 4226020X R0703642
4226020X R0802274 4226020X R0802854 4226020X S0402220 4226020X S0802204
4226030S R0202786 4226030S S0602139 4226030X R0202787 4226030X R0302650
4226030X R0702700 4226030X R0702937 4226040S S0302319 4226040X R0103476
4226040X R0403827 4226040X R1102486 4226040X S0602111 4226515S R0402170
4226515S R0503379 4226515S R1002435 4226515X R0402171 4226515X R0503715
4226515X R0702512 4226515X R0802301 4226515X R0802855 4226520S R0402172
4226520X R0303203
4226520X R0402682 4226520X R0602007 4226520X R0702697 4226520X R1102487 4226530X
R0402179 4226540X R0402174 4227015S R0402734 4227015S R0403621 4227015S
R0502094 4227015S R0502501 4227015X R0203747 4227015X R0802304 4227015X
S0602112 4227020S R0202154 4227020S R0402175 4227020S R0502548 4227020S
R0602241 4227020S R0602595 4227020S S0102151 4227020X R0402176 4227020X
R0402735 4227020X R0502095 4227020X R0602008 4227020X R0702699 4227020X
R0702934 4227020X R0703246 4227020X R0802134 4227020X R0802302 4227020X
R0802866 4227030S S0402222 4227030X R0402177 4227030X R0402760 4227040S R0402178
4227040S R0502096 4227040X R0503680 4227040X R0702936 4227040X R0802303
4227040X S0602113.
b) New Lots with October 2003 or newer dating embedded in lot number
("1003" MMYY in the second to fifth digit of Lot Number) and any
older ones with a Green Dot indicating that they passed Cordis Inspection ARE
NOT COVERED. The following previously uninspected lots were covered under the
recall: AVIATOR ITEM_NO LOT_NO 4224015S R0103043 4224015S R0202421 4224015S
R0403032 4224015S R0603169 4224015S R0902952 4224015S R11022314224015S S0602108
4224015X R0303535 4224015X R0402115 4224015X R0603722 4224015X R0902953
4224015X R1002434 4224015X S0502104 4224020S R0102364 4224020S R0102920
4224020S R0103968 4224020S R0202151 4224020S R0202862 4224020S R0203105 4224020S
R0203499 4224020S R0302900 4224020S R0502712 4224020S R0503318 4224020S
R0602462 4224020S R0702480 4224020S R0802055 4224020S R0802263
4224020S R0802850 4224020S R0802863 4224020S R1002174 4224020S S0102054
4224020S S0102686 4224020S S0202251 4224020S S0602109 4224020S S1002019
4224020S S1002209 4224020X R0103044 4224020X R0103196 4224020X R0103714
4224020X R0103969 4224020X R0202004 4224020X R0202206 4224020X R0203106
4224020X R0302095 4224020X R0303719 4224020X R0603339 4224020X R0702481
4224020X R0702652 4224020X R0702915 4224020X R0802056 4224020X R0802269
4224020X R0902477 4224020X R1002935 4224020X R1102003 4224020X R1102019
4224020X S0102050 4224020X S0602110 4224020X S1002020 4224030S R0202207
4224030S S0102051
4224030X R0202209 4224030X R0303023 4224030X R0603480 4224030X R0703380
4224030X R0802270 4224030X R1002567 4224030X R1002681 4224030X S0102052
4224030X S0303012 4224040S R0202005 4224040S R0902705 4224040S S0202252
4224040X R0202210 4224040X R0203503 4224040X R0502606 4224040X R0603723 4224040X
R0902562 4224040X R1202527 4224515S R0102923 4224515S R0303021 4224515S
R0702656 4224515S R1002682 4224515X R0202422 4224515X R0303534 4224515X
R0502832 4224520S R0302096 4224520S R0702482 4224520S S0302254 4224520X
R0202423 4224520X R0202863 4224520X R0402641 4224520X R0502377 4224530X
R0102922 4224530X R0302596 4224540X R0402885 4224540X S0602136 4225015S
R0103045 4225015S R0103398 4225015S R0103971 4225015S R0202697 4225015S
R0302599 4225015S R0403333 4225015S R0802864 4225015S S0502035 4225015S S0802199
4225015X R0103474 4225015X R0302097 4225015X R0303202 4225015X R0703132
4225015X R0902478 4225015X R1102232 4225015X S0402079 4225015X S0502134
4225020S R0102365 4225020S R0102366 4225020S R0102663 4225020S R0102703
4225020S R0103046 4225020S R0103715 4225020S R0202152 4225020S R0202698
4225020S R0202864 4225020S R0203107 4225020S R0302328 4225020S R0503679
4225020S R0702978
4225020S R0802271 4225020S R0802851 4225020S R0802865 4225020S S0102001
4225020S S0102415 4225020S S0802200 4225020X R0103475 4225020X R0103717
4225020X R0103970 4225020X R0202446 4225020X R0203108 4225020X R0203505
4225020X R0402642 4225020X R0403309 4225020X R0502092 4225020X R0503943
4225020X R0602336 4225020X R0702688 4225020X R0702916 4225020X R0702977
4225020X R0802272 4225020X R0802852 4225020X R0803122 4225020X R1002175
4225020X S0202007 4225020X S0402218 4225020X S0502383 4225020X S0802201
4225030S R0202565 4225030S S0502102 4225030X R0202566 4225030X S0202048
4225030X S0502103
4225040S R0302967 4225040S S0502135 4225040X R0103399 4225040X R0202699
4225040X R0403334 4225040X R0502378 4225040X R1002713 4225040X S0402219
4225515S R0202700 4225515S R0503714 4225515S S0802202 4225515X R0202788
4225515X R0303022 4225515X R0702689 4225515X R0802273 4225515X R1102020
4225520S R0202766 4225520S R0302647 4225520S R0602805 4225520X R0202767
4225520X R0302648 4225520X R0403033 4225520X R0602339 4225520X R0602812
4225520X S0502036 4225520X S0602137 4225530X R0402680 4225540X R0402116
4225540X R0403826 4226015S R0202768 4226015S R0203748 4226015S R0403620
4226015S R0502500
4226015S R0603490 4226015S R0702508 4226015S R1102583 4226015S S0802203
4226015X R0302649 4226015X R0602863 4226015X R0603487 4226015X R0902216
4226015X R1102230 4226015X S0202253 4226015X S1002212 4226020S R0102367
4226020S R0102665 4226020S R0102704 4226020S R0202003 4226020S R0202153
4226020S R0702510 4226020S R0702976 4226020S R0802853 4226020S R0902707
4226020S S0102149 4226020S S0102171 4226020S S0102262 4226020S S0302289
4226020S S0802180 4226020X R0103718 4226020X R0202785 4226020X R0203110
4226020X R0402117 4226020X R0502093 4226020X R0503154 4226020X R0602006
4226020X R0603725
4226020X R0702511 4226020X R0702690 4226020X R0702917 4226020X R0702975
4226020X R0703642 4226020X R0802274 4226020X R0802854 4226020X S0402220
4226020X S0802204 4226030S R0202786 4226030S S0602139 4226030X R0202787
4226030X R0302650 4226030X R0702700 4226030X R0702937 4226040S S0302319
4226040X R0103476 4226040X R0403827 4226040X R1102486 4226040X S0602111
4226515S R0402170 4226515S R0503379 4226515S R1002435 4226515X R0402171
4226515X R0503715 4226515X R0702512 4226515X R0802301 4226515X R0802855
4226520S R0402172 4226520X R0303203 4226520X R0402682 4226520X R0602007
4226520X R0702697
4226520X R1102487 4226530X R0402179 4226540X R0402174 4227015S R0402734
4227015S R0403621 4227015S R0502094 4227015S R0502501 4227015X R0203747
4227015X R0802304 4227015X S0602112 4227020S R0202154 4227020S R0402175
4227020S R0502548 4227020S R0602241 4227020S R0602595 4227020S S0102151
4227020X R0402176 4227020X R0402735 4227020X R0502095 4227020X R0602008
4227020X R0702699 4227020X R0702934 4227020X R0703246 4227020X R0802134
4227020X R0802302 4227020X R0802866 4227030S S0402222
4227030X R0402177 4227030X R0402760 4227040S R0402178 4227040S R0502096 4227040X
R0503680 4227040X R0702936 4227040X R0802303 4227040X S0602113.
RECALLING FIRM/MANUFACTURER Cordis Corporation, Miami Lakes, FL.
REASON A packaging defect may compromise the device's sterility barrier.
VOLUME OF PRODUCT IN COMMERCE 39,726 devices.
DISTRIBUTION Nationwide.
PRODUCT AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the
Operating Room at Hospitals).
CODE THE FOLLOWING SERIAL NUMBERS ARE INVOLVED IN THE RECALL: 1031 1073
1120 1162 1210 1256 1296 1348 1401 1475 1033 1074 1121 1163 1211 1257 1297 1349
1403 1476 1034 1075 1122 1164 1212 1258 1298 1350 1404 1477 1035 1077 1124 1165
1213 1260 1304 1351 1407 1478 1037 1078 1127 1168 1214 1261 1305 1354 1408 1480
1038 1080 1128 1169 1216 1262 1306 1355 1409 1481 1039 1081 1129 1170 1217 1264
1307 1356 1410 1482 1041 1085 1130 1174 1218 1266 1308 1357 1411 1483 1042 1086
1131 1177 1220 1267 1309 1360 1412 1485 1046 1087 1132 1178 1221 1268 1310 1361
1413 1486 1047 1089 1133 1180 1222 1269 1311 1365 1414 1487 1048 1090 1134 1183
1223 1270 1314 1366 1415 1488 1049 1091 1136 1184 1224 1271 1319 1372 1416 1489
1050 1092 1137 1185 1225 1272 1320 1375 1417 1492 1051 1094 1138 1186 1226 1274
1324 1376 1418 1493 1052 1096 1139 1187 1228 1275 1325 1377 1420 1494 1053 1098
1140 1188 1229 1276 1326 1378 1421 1495 1054 1101 1141 1189 1231 1277 1328 1379
1422 1496 1056 1103 1142 1190 1232 1278 1329 1380 1423 1497 1057 1104 1143 1191
1233 1279 1330 1381 1436 1498 1058 1105 1144 1192 1234 1280 1331 1382 1444 1499
1059 1106 1146 1193 1235 1281 1332 1383 1445 1500 1060 1107 1147 1195 1236 1283
1333 1384 1459 1563 1061 1108 1154 1196 1238 1284 1335 1386 1460 1568 1063 1109
1155 1197 1242 1285 1337 1388 1462 1569 1064 1110 1156 1198 1243 1286 1338 1390
1465 1570 1066 1111 1157 1201 1244 1289 1339 1393 1466 1571 1068 1112 1158 1205
1248 1290 1340 1395 1467 1572 1069 1114 1159 1206 1250 1291 1341 1396 1472 1070
1116 1160 1208 1253 1292 1342 1398 1473 1071 1117 1161 1209 1255 1294 1347 1400
1474.
RECALLING FIRM/MANUFACTURER Cardiocommand, Inc., Tampa, FL.
REASON The device may exhibit spurious heart rate increase during
esophageal atrial pacing during simultaneous adjacent use of electrosurgical
coagulation devices.
VOLUME OF PRODUCT IN COMMERCE 307 devices.
DISTRIBUTION Nationwide, Canada, Hong Kong, and the Netherlands.
PRODUCT PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty
Tracheostomy Tube REF # 511080.
CODE Lot Number K223373.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc, Keene, NH.
REASON
Lid tray
incorrectly labeled as Tube I.D.7.0mm instead of correct size 8.0mm.
VOLUME OF PRODUCT IN COMMERCE 30 cases (2/Case).
DISTRIBUTION AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, and WI.
PRODUCT Template Needle, Series 17, 20 cm, with Threaded Female hub and
Bent Stylet, Closed-End, Disposable. Packaged in single, 10, 15, 20 per
package.
CODE Lots F01068, F01099, F01100, and F01128.
RECALLING FIRM/MANUFACTURER Alpha-Omega Services, Inc., Bellflower, CA.
REASON Template needle may fracture leaving tip in patient.
VOLUME OF PRODUCT IN COMMERCE 1,290.
DISTRIBUTION LA, MN, CA, VA, CO, TX, ID, NY, KS, and WA.
PRODUCT
a) Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS.
b) Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile Catalog Number:
SLHAM33SS.
c) Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog Number: SLAAM33SS.
d) Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS.
e) Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS.
CODE
a) Lot Number: F2PN86704;
b) Lot number: F2PN86705;
c) Lot Number: F2PN86703;
d) Lot Numbers: F2JN63560 F2KN78263 F2MN78127 F2NN78129 F2NN86699 F2PN69885
R3AN96873 R3AN96873Q R3AN97497 R3AN97497Q R3DN04753 R3DN04754 R3HN06269
R3HN06271 R3HN06272 R3HN89115 R3HN89117 R3JN94935 R3JN94936 R3JN94938 R3JN94940;
e) Lot Numbers: F2KN69893 F2MN78131 F2NN82062 F2PN78264 R3DN04757 R3DN04758
R3HN06273 R3HN06274 R3HN89112 R3HN89113 R3HN93120 R3JN17305 R3JN25568 R3JN93121
R3KN94945 R3MN58189.
RECALLING FIRM/MANUFACTURER Millipore Corp., Bedford, MA.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 5,950 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT
a) 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1
ea. Carton labeling was similar to individual unit labeling, except for, ***Qty
50 ea.
b) RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE
USE ONLY, Qty 1 ea. Carton labeling was similar to individual unit labeling,
except for, ***Qty 50 ea.
c) One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, Lot
***, SINGLE USE ONLY, Latex Free, Quantity 50 Each.
d) One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot
***, SINGLE USE ONLY, Latex Free, Quantity 50 Each.
CODE
a) Lot numbers: 116040, 116039, 114795, 113887, 113886, 113232, 113230, 113095,
113027, 119110, 118134, 119988,
119989, 129179, 128393, 128028, 126119, 126118, 124951, 123197, 123198, 122461,
122033, 131793, 120731;
b) Lot numbers: 108273, 109600, 111314, 111229, 113984, 113932, 113931, 112991,
112514, 111588, 111589, 111558,
111557, 117867, 117866, 116471, 116163, 115616, 114992, 116865, 118714, 118055,
118054, 118053, 119421, 120628,
120521, 120021,120741, 120742, 122619, 122621, 122620, 123017, 123016, 123837,
126217, 125471, 125117, 124069,
126626, 126625, 127052, 127051, 128481, 128322, 127549, 127550, 129360, 129109,
129991, 130186, 130187;
c) Lot numbers: 010905, 011020, 020305, 020530, 020705, 020925, 030120, 031120,
030325, 030415;
d) Lot numbers: 020305, 010905, 020530, 020705, 020925, 021015, 021115, 030220,
030515, 030415, 030825, 030120.
RECALLING FIRM/MANUFACTURER Rusch Inc., Duluth, GA.
REASON Valve cap may become loose and enter the air circuitry.
VOLUME OF PRODUCT IN COMMERCE 539 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT EPROM and Control Software (embedded), version 5.08, for the
GammaMed 12i/t Afterloader.
CODE Serial numbers (Domestic units): 724 215 765 210 212 217 218 214
767 213 743 706708 784 727 795 710 899 702 898 820 219 750 757 894 799 852 821
216 788 202 873 786 896 797 826 709 889 848.
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Charlottesville, VA.
REASON Radiation treatment software could potentially cause a healthcare
practitioner to apply incorrect treatment regimen to patients undergoing
brachytherapy.
VOLUME OF PRODUCT IN COMMERCE 203.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Baxter System 1000 Single Patient Hemodialysis Delivery System; Model
SYS1000; all series 1000 instruments
labeled as System 1000, AltraTouch 1000.
b) Baxter Arena Hemodialysis Delivery System.
CODE
a) Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 26231;
b) Serial numbers 300001 through 300147.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., McGaw Park,
IL.
REASON These devices have the potential to overheat in the absence of a
Ground Fault Circuit Interrupter (GFCI). This heater system failure could
result in a fire.
VOLUME OF PRODUCT IN COMMERCE 28,435 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. Catalog
Number 384224.
b) BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile. Catalog
Number 380402.
CODE
a) Lot Number 3349840;
b) Lot Numbers 3356877, 3356485, 3352218.
RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy, Sandy,
UT.
REASON Splittable catheter introducer may not fully split or may
separate non-uniformly.
VOLUME OF PRODUCT IN COMMERCE 1,560 kits, 12,000 bulk units.
DISTRIBUTION Nationwide, Australia and Brazil.
PRODUCT Magnetic Resonance Imaging, System: Flexart, Visart and Excelart
Models.
CODE Flexart systems with software V3.51*R534 to V4.10*R551. Visart
systems with software V3.51*R234 to V4.10*R251. Excelart systems with software
V4.04*R251 to V4.10*R271.
RECALLING FIRM/MANUFACTURER Toshiba American Med Sys., Inc., Tustin, CA.
REASON Software anomally causes image slices to be in incorrect order.
VOLUME OF PRODUCT IN COMMERCE 24.
DISTRIBUTION Nationwide and PR.
PRODUCT Stayfuse brand intramedullary bone screw; MID 3.8x6 mm. Zimmer
part number 00-2227-003-001.
CODE Lot 77097300.
RECALLING FIRM/MANUFACTURER Pioneer Surgical Technology, Marquette, MI.
REASON Product labeled as size 3.8x6 mm implant may actually be size
4.3x6 mm implant.
VOLUME OF PRODUCT IN COMMERCE 318.
DISTRIBUTION Nationwide, Australia, Canada, Germany and United Kingdom.
PRODUCT Bardia® Complete Foley Kit, Single use only, Do not resterilize,
For urological use only, Reorder: 800518, 18 Fr., Inflate with 10ml sterile
water, Contents: 5cc
Silicone Elastomer-Coated Foley Catheter,
Waterproof
underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with
sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic
Tray. Catalog Number: 800518. CODE Lot Number: 76IN0317.
RECALLING FIRM/MANUFACTURER C. R. Bard, Inc., Urological Division,
Covington, GA.
REASON The Foley trays contain a 16 French catheter instead of an 18
French catheter as specified by the product insert/labeling.
VOLUME OF PRODUCT IN COMMERCE 1,100 units (110 cases).
DISTRIBUTION Nationwide.
PRODUCT Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery
System 8 Fr, 10mm x 60mm, Catalog Number: 6965.
CODE Lot Number: 6023979.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA.
REASON Incorrect label states stent covered with "Permalume
Covering", product is uncovered.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION CA, GA, MD, NY, OR, ND, PA, and the Netherlands.
PRODUCT
a) Cordis Endomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number
504300L. Cordis Biopsy Forceps 7F 104
cm Standard,
b) Product Number 504300L.
CODE a) and b) Lot Number 70403255.
RECALLING FIRM/MANUFACTURER Cordis Corporation, Miami Lakes, FL.
REASON Some devices may have incorrect inner label which shows Product #
504302L with a length of 50cm, while the outer label is correctly labeled as
Product # 504300L with the length of 104mm.
VOLUME OF PRODUCT IN COMMERCE 220.
DISTRIBUTION Nationwide, Netherlands, Canada and Mexico.
PRODUCT Portex Tracheal Tube Guide 15 Fr, non-sterile, Catalog Number:
153013.
CODE Lot Number: K221961.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Keene, NH.
REASON Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr.
VOLUME OF PRODUCT IN COMMERCE 230 units.
DISTRIBUTION CA, CO, FL, GA, IN, MA, MD, MI, NH, NC, NY, TX, and WA.
PRODUCT Cruciform Slit Valve.
CODE UbaV/V020/07-2003.
RECALLING FIRM/MANUFACTURER Phoenix Biomedical, Norristown, PA.
REASON Mislabeled: Product actually Single Valve.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA, and AZ.
PRODUCT Restoration T3 Revision Hip
System, Femoral Hip Prosthesis. Various lengths and Model numbers.
6260-3-014 T3 MOD REV DIST STM 14MMX225MM;
6260-3-015 T3 MOD REV DIST STM 15MMX225MM;
6260-3-016 T3 MOD REV DIST STM 16MMX225MM;
6260-3-017 T3 MOD REV DIST STM 17MMX225MM;
6260-3-018 T3 MOD REV DIST STM 18MMX225MM;
6260-3-019 T3 MOD REV DIST STM 19MMX225MM;
6260-3-020 T3 MOD REV DIST STM 20MMX225MM;
6260-3-022 T3 MOD REV DIST STM 22MMX225MM;
6230-3-024 T3 MOD REV DIST STM 24MMX225MM;
6260-3-114 T3 MOD REV DIST STM 14MMX265MM;
6260-3-115 T3 MOD REV DIST STM 15MMX265MM;
6260-3-116 T3 MOD REV DIST STM 16MMX265MM;
6260-3-117 T3 MOD REV DIST STM 17MMX265MM;
6260-3-118 T3 MOD REV DIST STM 18MMX265MM;
6260-3-119 T3 MOD REV DIST STM 19MMX265MM;
6260-3-120 T3 MOD REV DIST STM 20MMX265MM;
6260-3-122 T3 MOD REV DIST STM 22MMX265MM;
6260-3-124 T3 MOD REV DIST STM 24MMX265MM;
6260-3-214 KINKED T3 DIST STM 14MMX265MM;
6260-3-215 KINKED T3 DIST STM 15MMX265MM;
6260-3-216 KINKED T3 DIST STM 16MMX265MM;
6260-3-217 KINKED T3 DIST STM 17MMX265MM;
6260-3-218 KINKED T3 DIST STM 18MMX265MM;
6260-3-219 KINKED T3 DIST STM 19MMX265MM;
6260-3-220 KINKED T3 DIST STM 20MMX265MM;
6260-3-222 KINKED T3 DIST STM 22MMX265MM;
6260-3-224 KINKED T3 DIST STM 24MMX265MM;
6260-3-314 KINKED T3 DIST STM 14MMX305MM;
6260-3-315 KINKED T3 DIST STM 15MMX305MM;
6260-3-316 KINKED T3 DIST STM 16MMX305MM;
6260-3-317 KINKED T3 DIST STM 17MMX305MM;
6260-3-318 KINKED T3 DIST STM 18MMX305MM;
6260-3-319 KINKED T3 DIST STM 19MMX305MM;
6260-3-320 KINKED T3 DIST STM 20MMX305MM;
6260-3-322 KINKED T3 DIST STM 22MMX305MM;
6260-3-324 KINKED T3 DIST STM 24MMX305MM;
LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE;
6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY;
LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES;
LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
CODE All Lots.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ.
REASON Restoration T3 Revision Hip System distal stem has demonstrated
fractures.
VOLUME OF PRODUCT IN COMMERCE 8,986.
DISTRIBUTION Latin America, Canada, and Asia Pacific.
PRODUCT EnDura No-React Dural Substitute. Product comes in different
sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2%
benzyl alcohol.
CODE
Lot#, Catalog #, Description:
030911-NR, ENR-20210, 2CM X 10CM;
030911-NR, ENR-20404, 4CM X 4CM;
030911-NR, ENR-20506, 5CM X 6CM;
030808-NR, ENR-20610, 6CM X 10CM;
030811-NR, ENR-20610, 6CM X 10CM;
030911-NR, ENR-21012, 10CM X 12CM;
030924-NR, ENR-21012, 10CM X 12CM;
031027-NR, ENR-21212, 12CM Diameter.
RECALLING FIRM/MANUFACTURER Shelhigh, Inc., Union, NJ.
REASON The tamper-evident shrink band may fall off causing the user
uncertainty whether the product was opened and is still sterile.
VOLUME OF PRODUCT IN COMMERCE 1,002.
DISTRIBUTION Nationwide.
PRODUCT All Outpatient and Coolspot single ceiling or single track
Medical Examination Lights manufactured before August 2000. Products
manufactured during or after August 2000 contain a redesigned pivot assembly
and are not included in this recall.
CODE Affected products include:
Model
100540 Fleximount SGL Ceiling, Serial No.'s less than SC995486;
Model 100740 SGL Ceiling CS II, Serial No's less than SCCS990745;
Model 100580 SGL Trolley, Serial No.'s less than TRS962633; Model 100780 SGL
Trolley OP II, Serial No.'s less than STOP97417;
Model 102540 SGL Ceiling OP II, Serial No.'s less than SCOP003354.
RECALLING FIRM/MANUFACTURER Burton Medical Products Corp., Chatsworth,
CA.
REASON Pivot joint on these ceiling mount lights may fail and lights may
fall onto patients.
VOLUME OF PRODUCT IN COMMERCE 17,000 estimated.
DISTRIBUTION Nationwide.
PRODUCT
a) Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014
inch, Part Number 001-001096-1.
b) Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014
inch, Part Number 001-001096-3.
c) Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014
inch, Part Number 001-001096-4.
d) Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter
0.014 inch, Part Number
001-001232-3.
e) Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter
0.014 inch, Part Number 001-
f) Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014
inch, Part Number 001-001263-1.
CODE
a) Lots 0206-4004, 0207-4005, 0301-4015, 0301-4016, and 0304-4020;
b) Lots 0307-4029, 0307-4039, 0307-4042, 0307-4043, and 0307-4044;
c) Lots 0212-4014, 0307-4041, and 0308-4053;
d) Lots 0305-4024, 0305-4025, 0305-4026, 0306-4027, 0307-4028, 0307-4030,
0307-4031, and 0307-4050;
e) Lots 0211-4012, 0307-4037, 0308-4057, and 0308-4058;
f) Lot 0212-2027.
RECALLING FIRM/MANUFACTURER Stereotaxis, Inc., Saint Louis, MO.
REASON The magnet at the end of the guidewire could break off.
VOLUME OF PRODUCT IN COMMERCE 291 guidewires.
DISTRIBUTION IA, MA, MO, OK, TX, Germany and The Netherlands.
PRODUCT MediSense Precision QID Blood Glucose Test Strips. The product
is sold in box of 50 and 100. The NDC number for the 50 count box is
57599-7400-4. The NDC number for the 100 count box is 57599-7401-5.
CODE Lot number 89873 exp 4/30/04, Lot number 90524 exp. 11/30/04, Lot
number 90848 exp. 1/31/05, Lot number 90891 exp. 1/31/05, and Lot number 91326
exp. 3/31/05.
RECALLING FIRM/MANUFACTURER AmeriSource Bergen, Chesterbrook, PA.
REASON Potential counterfeit product/box.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide, PR, and the Bahamas.
PRODUCT
a) Faaborg patient lift/hoist, battery operated lifts. The PL series lifts have
electric parallel base widening, with a weight capacity of 365 lbs. to 550 lbs.
depending on the base model. The Users Guide refers to the lift as a
"Faaborghoist".
b) Faaborg patient lift/hoist, battery operated lifts. The VL series lifts have
electric V-shape base widening, with a weight capacity of 365 lbs.to 550 lbs.
depending on the base model.
c) Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic
series lifts have electric V-shape base widening, with a weight capacity of 210
lbs. to 365 lbs. depending on the base model.
CODE
a) All PL series models, all serial numbers;
b) All VL series models, all serial numbers;
c) All Solution/Nordic series models, all serial numbers.
RECALLING FIRM/MANUFACTURER Moving Solutions, Inc., Downers Grove, IL.
REASON Excessive wear of the hanger bar bolt, that connects the lift arm
to the sling spreader bar, may cause the bolt to snap allowing the patient to
fall.
VOLUME OF PRODUCT IN COMMERCE 856 lifts.
DISTRIBUTION Nationwide and Canada.
PRODUCT Laser system, DUO System, Class IV laser diode material processing
machine.
CODE None noted.
RECALLING FIRM/MANUFACTURER Coherent, Inc., Santa Clara, CA.
REASON Unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE 70 units.
DISTRIBUTION Nationwide.
PRODUCT Statscan digital radiographic system for Diagnostic Radiography.
CODE None supplied.
RECALLING FIRM/MANUFACTURER Lodox Systems, South Lyon, MI.
REASON The units are defective under 21 CFR 1010.2 in that the
identification and certification labels were inadequate or missing. In addition
there was inadequate testing and quality control procedures to establish
certification. This can result in misleading the purchasers and manufacturers
about requirements for certification of products introduced into commerce. The
required tracking for components may not be followed and thus a loss of
traceability.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and IL.
PRODUCT Coherent brand Quattro Diode Laser Systems; A Quattro FAP
System.
CODE Serial Numbers/Model Numbers: TFAP0004P-TFAP00048.
RECALLING FIRM/MANUFACTURER Coherent Inc Laser Group, Santa Clara, CA.
REASON Software problem that may cause the instrument to remain on and
emitting laser radiation after the interlock has been activated.
VOLUME OF PRODUCT IN COMMERCE 52 units.
DISTRIBUTION Nationwide.
PRODUCT
a) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 7mm x 21mm 80 cm
.018" REF PMB 8-7-21-80.
b) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 7mm x 18mm 80 cm
.018" REF PMB 8-7-18-80.
c) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 7mm x 14mm 80 cm
.018" REF PMB 8-7-14-80.
d) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 6mm x 21mm 80 cm
.018" REF PMB 8-6-21-80.
e) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 6mm x 18mm 80 cm
.018" REF PMB 8-6-18-80.
f) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 6mm x 14mm 80 cm
.018" REF PMB 8-6-14-80.
g) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 5mm x 21mm 80 cm
.018" REF PMB 8-5-21-80.
h)
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery
System, 5mm x 18mm 80 cm
.018" REF PMB 8-5-18-80.
i) ParaMount
Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System,
5mm x 14mm 80 cm
.018" REF PMB 8-5-14-80.
j) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 7mm x 21mm 80 cm
.014" REF PMB 4-7-21-80.
k) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 7mm x 18mm 80 cm
.014" REF PMB 4-7-18-80.
l) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 7mm x 14mm 80 cm
.014" REF PMB 4-7-14-80.
m) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 6mm x 21mm 80 cm
.014" REF PMB 4-6-21-80.
n) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 6mm x 18mm 80 cm
.014" REF PMB 4-6-18-80.
o) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 6mm x 14mm 80 cm
.014" REF PMB 4-6-14-80
p) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 5mm x 21mm 80 cm
.014" REF PMB 4-5-21-80.
q) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 5mm x 18mm 80 cm
.014" REF PMB 4-5-18-80.
r) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and
Delivery System, 5mm x 14mm 80 cm
.014" REF PMB 4-5-14-80.
s) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80.
t) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 7mm x 18mm 80 cm .018" REF PMP 8-7-18-80.
u) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 7mm x 14mm 80 cm .018" REF PMP 8-7-14-80.
v) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80.
w) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 6mm x 18mm 80 cm .018" REF PMP 8-6-18-80.
x)
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 6mm x 14mm 80 cm .018" REF PMP 8-6-14-80.
y) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 5mm x 21mm 80 cm .018" REF PMP 8-5-21-80.
z) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 5mm x 18mm 80 cm .018" REF PMP 8-5-18-80.
aa) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 5mm x 14mm 80 cm .018" REF PMP 8-5-14-80.
bb) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 7mm x 21mm 80 cm .014" REF PMP 4-7-21-80.
cc) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 7mm x 18mm 80 cm .014" REF PMP 4-7-18-80.
dd) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 7mm x 14mm 80 cm .014" REF PMP 4-7-14-80.
ee)
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 6mm x 21mm 80 cm .014 REF PMP 4-6-21-80.
ff)
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent
and Delivery System, 6mm x 18mm 80 cm .014" REF PMP 4-6-18-80.
gg) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 6mm x 14mm 80 cm .014" REF PMP 4-6-14-80.
hh) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 5mm x 21mm 80 cm .014" REF PMP 4-5-21-80.
ii) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 5mm x 18mm 80 cm .014" REF PMP 4-5-18-80.
jj) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable
Stent and Delivery System, 5mm x 14mm 80 cm .014" REF PMP 4-5-14-80.
CODE Lots 262849 through 445216.
RECALLING FIRM/MANUFACTURER Ev3, Inc., Saint Paul, MN.
REASON After stent deployment, resistance can occur when pulling the
deflated balloon back into the guiding catheter and this can result in an
increased procedure time.
VOLUME OF PRODUCT IN COMMERCE 446 units.
DISTRIBUTION Nationwide, China and Ireland.
PRODUCT ATS Open Pivot Mechanical Heart Valve.
CODE 500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all
products shipped to the field before January 31, 2002.
RECALLING FIRM/MANUFACTURER ATS Medical, Inc, Minneapolis, MN.
REASON Normally functioning prosthesis may have been placed on the valve
holder mechanism in reverse position.
VOLUME OF PRODUCT IN COMMERCE 56,266.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) CXP software, Part No. 623560.
b) Cytomics MXP Software, Part No. 623688.
c) Cytomics RXP Software, Part Numbers: 175488, 6418489, 175260, 175261,
175262, 175263, 175264, 175265.
CODE a), b) and c) Version 1.0.
RECALLING FIRM/MANUFACTURER Beckman Coulter Inc, Brea, CA.
REASON Software anomaly. Sample ID and the Run Date may become fixed
within a header on the FlowPAGE printout. All samples subsequently run, with
results printed using the FlowPAGE print format, will have the fixed Sample ID
and Run Date, rather than the correct Sample ID and Run Date.
VOLUME OF PRODUCT IN COMMERCE 418.
DISTRIBUTION Nationwide and Canada.
PRODUCT HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester
Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT;
HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT;
HEK10/150CPUT.
CODE Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17;
03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
RECALLING FIRM/MANUFACTURER Datascope Corporation, Montvale, NJ.
REASON Water permeability of the patch is out of specification.
VOLUME OF PRODUCT IN COMMERCE 710 units.
DISTRIBUTION Nationwide.
PRODUCT Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue Flex Tip
Arrowgard Blue Curved Catheter for high Volume Ifusions.
CODE
Product number AK-22142-CF Lot numbers RF2035008, RF2067620, RF2100365,
RF3023691, RF3045916, RF3078012, RF3089042, RF3099786, RF3121691, and RF3122085.
Product number AK-22142-CFSP Lot numbers RF2046619, RF2046669, RF3099895, and
RF3111053. Product number AK-22142-F Lot numbers RF1105891, RF2100885,
RF3088793, RF3089028, RF3089202, RF3099359, RF3100354, RF4012646. Product
number AK-25142-CF Lot number RF1080802, RF1094019, RF2010218, RF2067624,
RF2100633, RF2100886, RF3067453, RF3088794, RF3099633, RF3100446, and
RF3121805. Product number AK-25142-CFSP Lot numbers RF2010219, RF2046670,
RF3100573, and RF3111264. Product number AK-25142-F Lot numbers RF1104566,
RF3024351, RF3034977, RF3056501, RF3088861, RF3089029, RF3099313, and
RF3100355. Product number CS-22142-CF Lot numbers RF1028262, RF1033063,
RF1105890, RF2099516, RF2111093, RF3013358, RF3077978, RF3088513, RF3099272,
and RF3100452. Product number CS-22142-F Lot numbers RF1033064, RF2100484,
RF3045575, RF3088456, and RF3051547. Product number CS-25142-CF Lot numbers
RF1082563, RF1104918, RF1105889, RF2089343, RF2100890, RF2111125, RF3056376,
RF3067264, and RF3099410. Product number CS-25142-F Lot numbers RF1104919,
RF2111094, RF2111192, RF2111673, RF3023765, RF3035176, RF3045410, RF3056617,
RF3099369, RF3121572, and RF4012292.Product number CS-26142-F Lot numbers
RF2111134, RF2111290, RF3078240, RF3088795, RF3099586, RF3100056, RF3100272,
RF3111001, RF3111434, and RF3121623.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Reading, PA.
REASON Catheter slips out of the suture wing during use.
VOLUME OF PRODUCT IN COMMERCE 6,610 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm
length, Item Numbers: 53126 and
55602.
b)
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.0 cm
length, Item Numbers: 53128 and
55604.
c) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.2 cm
length, Item Numbers: 53130 and
55606.
d) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.5 cm
length, Item Numbers: 53132 and
55608.
e)
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.7 cm
length, Item Numbers: 53134 and
55610.
f) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.0 cm
length, Item Numbers: 53136 and
55612.
g) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.3 cm
length, Item Numbers: 53138 and
55614.
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube h) Kit, 14 Fr., 2.5 cm
length, Item Numbers: 53140 and
55616.
i) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.7 cm
length, Item Numbers: 53142 and
55618.
j) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 3.0 cm
length, Item Numbers: 53144 and
55620.
k) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 3.5 cm
length, Item Number: 55622.
l) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 4.0 cm
length, Item Number: 55624.
m) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 4.5 cm
length, Item Number: 55626.
n) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 0.8 cm
length, Item Numbers: 54146 and
55628.
o) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.0 cm
length, Item Numbers: 54148 and
55630.
p) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.2 cm
length, Item Numbers: 54150, 55275,
55632.
q) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.5 cm
length, Item Numbers: 54152 and
55634.
r) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.7 cm
length, Item Numbers: 54154, 55636.
s) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.0 cm
length, Item Numbers: 54156 and
55638.
t) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.3 cm
length, Item Numbers: 54158 and
55640.
u) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.5 cm
length, Item Numbers: 54160 and
55642.
v)
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.7 cm
length, Item Number: 55644.
w) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 3.0 cm
length, Item Number: 55646.
x) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 3.5 cm
length, Item Numbers: 54166 and
55648.
y) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 4.0 cm
length, Item Number: 55650.
z) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 4.5 cm
length, Item Number: 55652.
aa)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 0.8 cm
length, Item Number: 55654.
bb)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.0 cm
length, Item Numbers: 54240 and
55656.
cc)Ross
Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.2 cm length,
Item Numbers: 54242 and
55658.
dd)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.5 cm
length, Item Numbers: 54244 and
55660.
ee)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.7 cm
length, Item Numbers: 54246 and
55662.
ff)Ross
Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.0 cm length,
Item Numbers: 54248 and
55664.
gg)Ross
Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.3 cm length,
Item Numbers: 54250 and
55666.
hh)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.5 cm
length, Item Numbers: 54252 and
55668.
ii)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.7 cm
length, Item Number: 55670.
jj)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.0 cm
length, Item Numbers: 54256 and
55672.
kk)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.5 cm
length, Item Numbers: 54258 and
55674.
ll)Kit, 18 Fr., 4.0 cm length, Item Numbers: 54260 and 55676.
mm)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 4.5 cm
length, Item Numbers: 54262 and
55678.
nn)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 0.8 cm
length, Item Numbers: 54186 and
55680.
oo)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.0 cm
length, Item Number: 55682.
pp)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.2 cm
length, Item Numbers: 54190 and
55684.
qq)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.5 cm
length, Item Numbers: 54192 and
55684.
rr)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.7 cm
length, Item Numbers: 54194 and
55688.
ss)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.0 cm
length, Item Numbers: 54196 and
55690.
tt)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.3 cm
length, Item Number: 55692.
uu)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.5 cm
length, Item Numbers: 54200 and
55694.
vv)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.7 cm
length, Item Numbers: 54202 and
55696.
ww)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 3.0 cm
length, Item Numbers: 54204 and
55698.
xx)Ross
Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 3.5 cm length,
Item Numbers: 54206 and
55700.
yy)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 4.0 cm
length, Item Numbers: 54208 and
55702.
zz)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 4.5 cm
length, Item Numbers: 54210 and
55704.
aaa)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 1.5 cm
length, Item Number: 55706.
bbb)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 1.7 cm
length, Item Numbers: 54214 and
55708.
ccc)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.0 cm
length, Item Number: 55711.
ddd)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.3 cm
length, Item Numbers: 54218 and
55713.
eee)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.5 cm
length, Item Numbers: 54220 and
55715.
fff)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.7 cm
length, Item Numbers: 54222 and
55717.
ggg)Ross
Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.0 cm length,
Item Numbers: 54224 and
55719.
hhh)Ross
Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.5 cm length,
Item Numbers: 54226 and
55721.
iii)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm
length, Item Number: 55723.
jjj)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.5 cm
length, Item Numbers: 54230 and
55725.
CODE
a) Lot Numbers: 73088GZ00, 75182GZ00, 78309GZ00, 72040GZ00, 75183GZ00,
77269GZ00, 79340GZ00, 79365GZ00;
b) Lot Numbers: 73089GZ00, 74144GZ00, 75198GZ00, 79364GZ00, 80424GZ00,
80425GZ00, 73083GZ00, 74134GZ00, 75199GZ00, 77283GZ00, 79367GZ00, 80426GZ00;
c) Lot Numbers: 71030GZ00, 73102GZ00, 74135GZ00, 75184GZ00, 79363GZ00,
80423GZ00, 72065GZ00, 74112GZ00, 75164GZ00, 76240GZ00, 80421GZ00;
d) Lot Numbers: 72064GZ00, 77284GZ00, 78328GZ00, 80422GZ00, 71031GZ00,
74109GZ00, 76230GZ00, 79357GZ00, 80427GZ00;
e) Lot Numbers: 74136GZ00, 77286GZ00, 79342GZ00, 82505GZ00;
f) Lot Numbers: 82460GZ00, 82474GZ00;
g) Lot Numbers: 73095GZ00, 78311GZ00, 76231GZ00, 78312GZ00;
h) Lot Numbers: 73096GZ00, 74137GZ00, 76217GZ00, 77256GZ00, 80385GZ00,
72062GZ00, 76218GZ00, 78313GZ00;
i) Lot Numbers: 71032GZ00, 73090GZ00, 77272GZ00, 74157GZ00, 78302GZ00;
j) Lot Numbers: 77271GZ00 and 74113GZ00;
k) Lot Number: 79376GZ00;
l) Lot Number: 82529GZ00;
m) Lot Numbers: 73084GZ00 and 78326GZ00;
n) Lot Numbers: 72038GZ00, 78315GZ00, 80399GZ00, 75201GZ00, 78308GZ00,
79358GZ00;
o) Lot Numbers: 72039GZ00, 74158GZ00, 77257GZ00, 80404GZ00, 76219GZ00,
79359GZ00;
p) Lot Numbers: 74148GZ00, 72060GZ00, 74149GZ00, 75187GZ00, 77287GZ00, 75202GZ00,
80420GZ00;
q) Lot Numbers: 74138GZ00, 75200GZ00, 73092GZ00 76232GZ00;
r) Lot Numbers: 74150GZ00, 79374GZ00;
s) Lot Numbers: 78304GZ00, 73085GZ00, 74151GZ00;
t) Lot Numbers: 76241GZ00, 74111GZ00, 75203GZ00, 78316GZ00, 80387GZ00;
u) Lot Numbers: 75165GZ00, 78305GZ00, 71016GZ00, 73103GZ00, 75185GZ00,
76233GZ00, 79360GZ00, 80382GZ00;
v) Lot Numbers: 74139GZ00, 75186GZ00, 76242GZ00, 80383GZ00;
w) Lot Numbers: 76243GZ00, 78327GZ00, 79361GZ00;
x) Lot Numbers: 77258GZ00, 72061GZ00, 74140GZ00, 75204GZ00, 76244GZ00,
79362GZ00;
y) Lot Numbers: 74110GZ00, 75167GZ00, 75197GZ00, 78317GZ00, 80384GZ00;
z) Lot Numbers: 75188GZ00, 76245GZ00, 82476GZ00;
aa)Lot Numbers: 82525GZ00, 85665GZ00, 90020GZ00, 91086GZ00, 91151GZ00,
92207GZ00, 93303GZ00;
bb)Lot Numbers: 74114GZ00, 75168GZ00, 75196GZ00, 79375GZ00, 84570GZ00,
85666GZ00, 88816GZ00, 91116GZ00, 92204GZ00, 95383GZ00;
cc)Lot Numbers: 76220GZ00, 82475GZ00, 83539GZ00, 86696GZ00, 88819GZ00,
89937GZ00, 90022GZ00, 92218GZ00;
dd)Lot Numbers: 73091GZ00, 84610GZ00, 88823GZ00, 92208GZ00;
ee)Lot Numbers: 02567GZ00, 03609GZ00, 82466GZ00, 83558GZ00, 85682GZ00,
86705GZ00, 87761GZ00, 88821GZ00, 89934GZ00, 91091GZ00, 92239GZ00, 94343GZ00,
95412GZ00, 84604GZ00, 89879GZ00, 91162GZ00;
ff)Lot Numbers: 81443GZ00, 82480GZ00, 84580GZ00, 84619GZ00, 85663GZ00,
87800GZ00, 88820GZ00, 89935GZ00, 90005GZ00, 91113GZ00, 91150GZ00, 94326GZ00,
84604GZ00, 89879GZ00, 91162GZ00;
gg)Lot Numbers: 82497GZ00, 82523GZ00, 84620GZ00, 85645GZ00, 86702GZ00,
87765GZ00, 89917GZ00, 90017GZ00, 90988GZ00, 91084GZ00, 92229GZ00, 92246GZ00,
84572GZ00, 87772GZ00, 89938GZ00, 91079GZ00;
hh)Lot Numbers: 82481GZ00, 82498GZ00, 84621GZ00, 85664GZ00, 86694GZ00,
87801GZ00, 88817GZ00, 89971GZ00, 91067GZ00, 92180GZ00, 93276GZ00, 94341GZ00,
82486GZ00, 85648GZ00, 85674GZ00, 88850GZ00, 89958GZ00, 94314GZ00;
ii)Lot Numbers: 81439GZ00, 82483GZ00, 85639GZ00, 86703GZ00, 87773GZ00,
88846GZ00, 89916GZ00, 90021GZ00, 91087GZ00, 92205GZ00;
jj)Lot Numbers: 82499GZ00, 84578GZ00, 85638GZ00, 87762GZ00, 88818GZ00,
89936GZ00, 90018GZ00, 91085GZ00, 91132GZ00, 92223GZ00, 93295GZ00, 94339GZ00,
82500GZ00, 82524GZ00, 84573GZ00, 85667GZ00, 86735GZ00, 89910GZ00, 90987GZ00, 91133GZ00,
94353GZ00;
kk)Lot Numbers: 83553GZ00, 85646GZ00, 87763GZ00, 88849GZ00, 89878GZ00,
89918GZ00, 90032GZ00, 90989GZ00, 92193GZ00, 93262GZ00, 94324GZ00, 82526GZ00,
85640GZ00, 86704GZ00, 87779GZ00, 89880GZ00, 90986GZ00, 91080GZ00, 93305GZ00;
ll)Lot Numbers: 12905GZ00, 83554GZ00, 84609GZ00, 87769GZ00, 88811GZ00,
89968GZ00, 91114GZ00, 92202GZ00, 93302GZ00, 01516GZ00, 10819GZ00, 82484GZ00,
86706GZ00, 89919GZ00, 92206GZ00, 94370GZ00;
mm)Lot Numbers: 81438GZ00, 82470GZ00, 83540GZ00, 85647GZ00, 86734GZ00,
88812GZ00, 89939GZ00, 90019GZ00, 91115GZ00, 92203GZ00, 92247GZ00, 93292GZ00,
95382GZ00, 10808GZ00, 82501GZ00, 84593GZ00, 86707GZ00, 89920GZ00, 90033GZ00, 91134GZ00,
92243GZ00;
nn)Lot Numbers: 84605GZ00, 88859GZ00, 91167GZ00, 81446GZ00, 83543GZ00,
85650GZ00, 86740GZ00, 89888GZ00, 91061GZ00, 91159GZ00, 94354GZ00;
oo)Lot Numbers: 81448GZ00, 82465GZ00, 83544GZ00, 84611GZ00, 85673GZ00,
86741GZ00, 88847GZ00, 89912GZ00, 90037GZ00, 91140GZ00, 93264GZ00, 94325GZ00;
pp)Lot Numbers: 02568GZ00, 83556GZ00, 88860GZ00, 96452GZ00, 10809GZ00,
84612GZ00, 86730GZ00, 88839GZ00, 89889GZ00, 91065GZ00, 92224GZ00, 94355GZ00;
qq)Lot Numbers: 01517GZ00, 81444GZ00, 82471GZ00, 87760GZ00, 93277GZ00,
81448GZ00, 82465GZ00, 83544GZ00, 84611GZ00, 85673GZ00, 86741GZ00, 88847GZ00,
89912GZ00, 90037GZ00, 91140GZ00, 93264GZ00, 94325GZ00;
rr)Lot Numbers: 01496GZ00, 10807GZ00, 84606GZ00, 84613GZ00, 86744GZ00,
89891GZ00, 90038GZ00, 91082GZ00, 93265GZ00, 96436GZ00, 96474GZ00;
ss)Lot Numbers: 84583GZ00, 85668GZ00, 94337GZ00, 01508GZ00, 03604GZ00,
84595GZ00, 86710GZ00, 88840GZ00, 91139GZ00, 94342GZ00;
tt)Lot Numbers: 84614GZ00, 88851GZ00, 91066GZ00, 91136GZ00, 94371GZ00;
uu)Lot NumbersL 84618GZ00, 89881GZ00, 89966GZ00, 84615GZ00.
vv)Lot Numbers: 82456GZ00, 85641GZ00, 86709GZ00, 89922GZ00, 91088GZ00,
84616GZ00, 89913GZ00;
ww)Lot Numbers: 81445GZ00, 84594GZ00, 85669GZ00, 86736GZ00, 87774GZ00,
89882GZ00, 90034GZ00, 90985GZ00, 91149GZ00, 84615GZ00;
xx)Lot Numbers: 82502GZ00, 83541GZ00, 84584GZ00, 86737GZ00, 87785GZ00,
88861GZ00, 89883GZ00, 89969GZ00, 90035GZ00, 91152GZ00, 93301GZ00, 84596GZ00,
88841GZ00, 89893GZ00, 91062GZ00;
yy)Lot Numbers: 02553GZ00, 82455GZ00, 83534GZ00, 84574GZ00, 85649GZ00,
86738GZ00, 87780GZ00, 87786GZ00, 89923GZ00, 90036GZ00, 90991GZ00, 91173GZ00,
92222GZ00, 82482GZ00, 83557GZ00, 87764GZ00, 93304GZ00;
zz)Lot Numbers: 82468GZ00, 83542GZ00, 86728GZ00, 86739GZ00, 89887GZ00, 89911GZ00,
90023GZ00, 91068GZ00, 91158GZ00, 92219GZ00, 93307GZ00, 95384GZ00, 83537GZ00,
85681GZ00, 86711GZ00, 89970GZ00, 91160GZ00, 95404GZ00;
aaa)Lot Numbers: 84622GZ00, 87776GZ00, 88852GZ00, 92200GZ00, 95385GZ00;
bbb)Lot Numbers: 83535GZ00, 87775GZ00, 88842GZ00, 90039GZ00, 94340GZ00,
02554GZ00, 84623GZ00, 86745GZ00,89927GZ00, 91166GZ00, 92241GZ00;
ccc)Lot Numbers: 12903GZ00, 85633GZ00, 86731GZ00, 87777GZ00, 90041GZ00,
92220GZ00;
ddd)Lot Numbers: 03605GZ00, 10811GZ00, 82503GZ00, 84579GZ00, 85683GZ00, 88830GZ00,
89924GZ00, 90040GZ00, 91168GZ00, 93275GZ00, 96437GZ00, 85634GZ00, 86732GZ00, 88843GZ00,
91154GZ00;
eee)Lot Numbers: 84571GZ00, 88831GZ00, 89894GZ00, 91137GZ00, 02576GZ00,
83547GZ00, 84608GZ00, 86692GZ00, 88809GZ00, 89940GZ00, 89950GZ00;
fff)Lot Numbers: 02544GZ00, 84581GZ00, 84607GZ00, 89925GZ00, 91161GZ00,
94338GZ00, 83536GZ00, 86713GZ00,
89895GZ00, 92232GZ00, 95386GZ00;
ggg)Lot Numbers: 84597GZ00, 86712GZ00, 88829GZ00, 91063GZ00, 94356GZ00,
01509GZ00, 83546GZ00, 85675GZ00, 86746GZ00, 88844GZ00, 91089GZ00, 92242GZ00;
hhh)Lot Numbers: 02545GZ00, 84582GZ00, 87788GZ00, 88848GZ00, 91090GZ00,
91153GZ00, 82487GZ00, 84598GZ00, 86693GZ00, 88862GZ00, 92178GZ00, 95405GZ00;
iii)Lot Numbers: 85635GZ00, 85670GZ00, 91064GZ00, 94320GZ00;
jjj)Lot Numbers: 03620GZ00, 83545GZ00, 85651GZ00, 87789GZ00, 89926GZ00, 92196GZ00, 92221GZ00, 85636GZ00,
89896GZ00, 91138GZ00.
RECALLING FIRM/MANUFACTURER Ross Products Division Abbott Laboratories,
Columbus, OH.
REASON
The
balloons may be defective as indicated by an increased number of early balloon
failures, which may result in tube displacement from patient.
VOLUME OF PRODUCT IN COMMERCE 61,160 kits.
DISTRIBUTION Nationwide, Australia, New Zealand, and Italy.
PRODUCT
a) Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S.
Part No: 7204823.
b) Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398.
c) Endocoupler 18 M M F.L, Autoclavable Catalog Number: 7207905, 7207905S.
d) Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M,
7204614S.
e) Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461.
CODE
a) Serial #s: SR 8433 SR 8472 SR 8504 SR 8562 SR 8391 SR 8506 SR 8538 SR 8555
SR 8392 SR 8395 SR 8489
SR 8494 SR 8554 SR 8471 SR 8485 SR 8477 SR 8568 SR 8513 SR 8514 SR 8394 SR 8520
SR 8493 SR 8567
SR 8569 SR 8396 SR 8533 SR 8561 SR 8534 7204823S SR 8623 SR 8422 SR 8563 SR
8590 SR 8577 SR 8591
SR 8628 SR 8495 SR 8576 SR 8627 SR 8426 SR 8490 SR 8499 SR 8587 SR 8573 SR 8428
SR 8574 SR 8578
SR 8580 SR 8589 SR 8565 SR 8566 SR 8498 SR 8564 SR 8620.
b) Serial #s: 50001621-2, 50001621-1.
c) Part No: 7207095 Serial #s: XF 819 XF 922 XF 951 XF 955 XF 960 XF 962 XF 963
XF 967 XF 968 XF 990 XF 1033 XF 974 XF 976 XF 952 XF 835 XF 878 XF 1012 XF 1013
XF 1017 XF 1029 XF 1036 XF 1039 XF 1042 XF 811 XF 817 XF 820 XF 920 XF 965 XF
971 XF 977 XF 980 XF 988 XF 991 XF 992 XF 996 XF 1002 XF 1004 XF 1020 XF 1025
XF 1026 XF 1030 XF 1032 XF 1045 XF 1046 XF 957 XF 203 XF 704 XF 954 XF 959 XF
969 XF 970 XF 987 XF 1001 XF 801 XF 816 XF 712 XF 301 XF 909 XF 917 XF 848 XF
863 XF 864 XF 894 XF 904 XF 910 XF 918 XF 865 XF 868 XF 829 XF 800 XF 806 XF
888 XF 892 XF 953 XF 964 XF 966 XF 851 XF 858 XF 879 XF 807 XF 808 XF 897 XF
925 XF 935 XF 956 XF 958 XF 961 XF 716 XF 818 XF 994 XF 1009 XF 1037 Part No:
7207905S Serial #s: XF 144 XF 456 XF 709 XF 779 XF 884 XF 699 XF 748 XF 529 XF
669 XF 850;
d) Part No: 7204614 Serial #s: QW 17251 QW 17264 QW 17064 QW 17301 QW 17240 QW
17312 QW 17271 QW 17311 QW 17236 QW 17274 QW 17256 QW 17266 QW 16939 QW 17296
QW 17187 QW 17306 QW 17062 QW 17235 QW 17063 QW 17304 QW 17245 QW 17309 QW
17299 QW 17182 QW 17061 QW 17241 QW 17065
QW 17246 QW 17316 QW 17250 QW 16979 QW 17294 QW 16984 QW 17269 QW 17058 QW
17276 QW 17186 QW 17281 QW 17279 QW 17286 QW 17307 QW 17290 QW 16945 QW 17291
QW 17314 QW 17317 QW 17255 QW 17320 QW 16946 QW 16944 QW 16949 QW 16960 QW
17059 QW 16963 QW 17060 QW 17057 QW 17066
Part No: 7204614M Serial #s: QW 14735 QW 5709 QW 7623 QW 14560 QW 2701 QW 13306
QW 10665 QW 15180 QW 15114 QW 16358 QW 6058 QW 7968 QW 10807 Part No: 7204614S Serial
#s: QW 12364 QW 15063 QW 18182 QW 17009 QW 18017 QW 18011 QW 6103 QW 14098 QW
18016 QW 17037 QW 11192 QW 18183 QW 17007 QW 16545 QW 14024 QW 16291 QW 9983 QW
17035 QW 12988 QW 17031 QW 18180 QW 15194 QW 11626
QW 17000 QW 15987 QW 16068 QW 16360 QW 18004 QW 15852 QW 16111 QW 16581 QW
11689 QW 15148 QW 18173 QW 13125 QW 17033 QW 15878 QW 15895 QW 17039 QW 18005
QW 17036 QW 10883 QW 10101 QW 14937 QW 12600 QW 18195 QW 17014 QW 12172 QW
13286 QW 14804 QW 15494 QW 16591 QW 18197
QW 12065 QW 17038 QW 11699 QW 15091 QW 13797 QW 15941 QW 18009 QW 6327 QW 12382
QW 16160 QW 13645 QW 14801 QW 16723 QW 17011 QW 18014 QW 15446 QW 17016 QW
13867 QW 13994 QW 9574 QW 15607 QW 15352 QW 16296 QW 13203 QW 14232 QW 11717 QW
14071 QW 15111 QW 18027;
e) Part No: 7205461 Serial #s: UE 1130 UE 1234 UE 1142 UE 127 UE 1143 UE 1212
UE 1216 UE 1222 UE 1226
UE
1217 UE 1145 UE 1227.
RECALLING FIRM/MANUFACTURER Smith And Nephew, Inc. Endoscopy Division,
Andover, MA.
REASON Endocouplers assembled with screws that cannot be effectively
sterilized .
VOLUME OF PRODUCT IN COMMERCE 305 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Xact(tm) Drop Seat Base, a plastic seat support in Xact(tm)
Integrated and Xact Individual w/Drop seat Base Wheelchair cushions.
CODE Drop seat bases are not labeled with serial or code numbers, but
are found on all wheelchair cushions labeled as Xact Integrated and Xact
Individual w/Drop Seat Base.
RECALLING FIRM/MANUFACTURER Action Products Inc, Hagerstown, MD.
REASON Wheelchair seat may not properly support the user due to cracks
in the plastic seat base.
VOLUME OF PRODUCT IN COMMERCE 819 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT AngioDynamics Incorporated 21 Gauge Micro Access Needle,
B-Bevel-4 cm length, catalog No. 06506803.
CODE Lot W24005, Use By 2005-03.
RECALLING FIRM/MANUFACTURER Empath Medical, Inc., Plymouth, MN.
REASON
The product
is labeled as sterile product but had not been sterilized.
VOLUME OF PRODUCT IN COMMERCE 20/ten-pack kits.
DISTRIBUTION NY.
PRODUCT DCTM Digital Ceiling Tube Mount, model DCTM; a fully
counter-balanced radiographic x-ray tube suspension system designed to
facilitate a wide range of procedures.
CODE Model DCTM, serial numbers 00182-0303, 00337-0303, 00901-0503,
00948-0503, 02082-0703, 02083-0703, 02152-0703, 02153-0703, 02187-0703,
02188-0703, 02289-0703, 02460-0803, 02492-0803, 02493-0803, 02581-0803,
02730-0803, 02805-0803, 02809-0903, 02810-0903, 02811-0903, 02812-0903,
02866-0903, 02918-0903, 02989-0903, 02990-0903, 02991-0903, 03147-0903,
03148-0903, 03149-0903, 03457-1003, 03458-1003, 03544-1003, 03545-1003,
03624-1003, 03625-1003, 03756-1003, 03757-1003, 03888-1103, 03956-1103,
04085-1103, 04122-1103, 04154-1103, 04236-1103, 04248-1103, 04264-1103,
04371-1203, 04433-1203, 04439-1203, 04480-1203, 04529-1203, 04572-1203,
04634-1203, 04659-1203, 04709-1203, 00032-0104, 00085-0104, WG0031-0102-R.
RECALLING FIRM/MANUFACTURER Del Medical Systems Group, Franklin Park, IL.
REASON There is a potentially defective worm gear in the tension
adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube
Support System for overhead x-ray units.
VOLUME OF PRODUCT IN COMMERCE 57 units.
DISTRIBUTION Nationwide, Canada, Panama and Pakistan.
PRODUCT
a) Apex Pilot Shaft, 10mm, catalog number: 690110.
b) Apex Pilot Shaft, 11.5mm, catalog number: 69011.
c) Apex Pilot Shaft, 13mm, catalog number: 690113.
d) Apex Pilot Shaft, 14.4mm, catalog number: 690114.
e) Apex Pilot Shaft, 16mm, catalog number: 690116.
f)
Apex Pilot Shaft, 17.5mm, catalog number: 690117.
CODE
a) Lot numbers: 128, 214;
b), c), d), e), and f) Lot numbers: 052, 113, 214.
RECALLING FIRM/MANUFACTURER Apex Surgical, LLC, Lakeville, MA.
REASON Pilot shaft may break during reaming or broaching of the femur.
VOLUME OF PRODUCT IN COMMERCE 172.
DISTRIBUTION CT, OH, FL, OK, TX, RI, NV, and SC.
PRODUCT Restoration Hip system Cylindrical Distal Extension. Catalog
numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm,
19.5mm, and 10.5mm extensions.
CODE Lots: 96910501, 96949401, 96940901, 96950901.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ.
REASON The Cylindrical Distal Extensions were incorrectly coded and
packaged.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION GA, MN, and Sweden.
PRODUCT
3M Attest
Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, in boxes
of 50 per box.
CODE Lot # 2006-01 AN.
RECALLING FIRM/MANUFACTURER 3M Company/Medical Division, St Paul, MN.
REASON The 3M Attest 1292 Rapid Readout Biological Indicators for steam
sterilization may contain ampoules which may result in a false negative readout
as 3 hours.
VOLUME OF PRODUCT IN COMMERCE 90,000 ampoules.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Medtronic Bravo pH Monitoring System Receiver.
CODE All serial numbers less than 400,000 are involved.
RECALLING FIRM/MANUFACTURER Medtronic Gastroenterology / Urology,
Shoreview, MN.
REASON The product's rear panel label could smear during use causing the
serial number to be unreadable. This has the remote possibility of resulting in
patient data from diagnostic tests being mixed-up or attributed to the wrong
patient.
VOLUME OF PRODUCT IN COMMERCE 1468.
DISTRIBUTION Nationwide and Internationally.
PRODUCT ProbeChek Vysis UroVysion Control Slides, for Fluorescence in
situ Hybridization (FISH) using Vysis
UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal
human male
lymphoblast cell line (negative target) and fixed culture human bladder
carcinoma cell line specimens
(positive), applied to glass microscope slides, catalog #30-805070, 3 slides
per kit.
CODE Lot 47228, exp. 05/04 and lot 49023, exp. 08/04.
RECALLING FIRM/MANUFACTURER Vysis, Downers Grove, IL.
REASON Some of the control slides did not have adequate cells deposited
upon their surface.
VOLUME OF PRODUCT IN COMMERCE 234 kits.
DISTRIBUTION Nationwide, Germany and Japan.
PRODUCT Salvart Oral Moisturizer, 2.5 fl oz. aerosol cans. OTC, Item
number 0386-0009-75.
CODE Lots: #031751F09, #031761F10, #031771F11, Expiration date for all
lots: June 2005.
RECALLING FIRM/MANUFACTURER Gebauer Co., Cleveland, OH.
REASON The actuator valve is defective, which may allow the valve to
remain open after use and continue to spray until the can is empty.
VOLUME OF PRODUCT IN COMMERCE 25,561.
DISTRIBUTION Nationwide.