DECEMBER 2004
WEEK
ENDING DECEMBER 4
PRODUCT
a) Access AED (without audio record) Model Number: 9100-0100-0.
b) Access AED Package (without audio record) Model Number: 9100-0150-0.
c) Access AED (with audio record) Model Number: 9100-0100-1.
d) Access AED Package (with audio record) Model Number: 9100-0150-1.
e) Access ALS (Advanced Life Support) Model Number: 9100-0100-2.
f) Access ALS Package Model Number: 9100-0150-2.
g) Access AED PAD (without ECG trace) ‚Public Access Defibrillator Model Number: 9100-0010-0.
h) Access AED PAD Package (without ECG trace) Model Number: 9100-0015-0.
CODE Serial Numbers: 075180 through 084760.
RECALLING FIRM/MANUFACTURER Access Cardio Systems, Concord, MA.
REASON Automated External Defibrillator device may fail to deliver shock due to a faulty
circuit board.
VOLUME OF PRODUCT IN COMMERCE 8,636 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Electric Positioning Lift Chairs.
CODE Model Numbers: C20, C30, GL358S, GL358L, TMR58, TMR540, TMR560, TMR570t, TMR571,
TMR585, DMR670, TMR805, and TMR450.
RECALLING FIRM/MANUFACTURER Pride Mobility Products Corp., Exeter, PA.
REASON The heating pad on these Lift Chairs may tear at the entry point causing a short
and/or overheating, which can damage the chair.
VOLUME OF PRODUCT IN COMMERCE 532 units.
DISTRIBUTION Nationwide.
PRODUCT Medtronic Midas Rex Legend Lubricant/Diffuser Cartridge Catalog number PA100-A.
CODE A5972-V01; A5982-V01; A5991-V01; A5992-V01; A6308-V01through A6327-V01; A6666-V01
through A6684-V01; A6686-V01 through A6691-V01; A6919-V01 through A6934-V01;
A7184-V01 through A7188-V01; A7194-V01through A7198-V01; A7495-V01 through A7501-V01;
A7520-V01; A7521-V01; and A7525-V01.
RECALLING FIRM/MANUFACTURER Power Surgical Solutions, Fort Worth, TX.
REASON Reduced plastic thickness of lubricant/diffuser cartridge can crack under pressure
causing leakage of lubricant as visible mist (appearance of smoke).
VOLUME OF PRODUCT IN COMMERCE 12,286 cases of 4 units per case.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Instrument
b) Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument.
CODE
a) Serial numbers RP-10000 through RP-11060;
b) Serial numbers LP-10000 through LP-10951.
RECALLING FIRM/MANUFACTURER Premier Dental Products Co., Plymouth Meeting,
PA.
REASON Cryogen can escape from canister through the seal ring.
VOLUME OF PRODUCT IN COMMERCE 2,012 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists
of a test plate, and various reagents in individual vials (positive and negative
controls, calibrator, diluent, substrate, stop solution, wash buffer.). The
individual vials are secured in the card board box. The test kit which is coated
with the appropirate antigen, are placed in a foil pouch, which is also placed
in the middle of the cardboard box.
CODE Lot 04027128 exp 2005-10.
RECALLING FIRM/MANUFACTURER Zeus Scientific, Inc., Somerville, NJ.
REASON During packaging, Lyme plates were packaged in this kit in error.
VOLUME OF PRODUCT IN COMMERCE 25 kits.
DISTRIBUTION Nationwide and Israel.
PRODUCT IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2
bottles of Negative and Positive controls of 9 mL each. These are prepared with
recalcified human plasma and the preservative is Sodium Azide. The Negative
Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG
antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV
diluted with Negative Control.
CODE Lot # 18220Q100 Exp. March 02, 2005.
RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc., Barceloneta,
PR.
REASON IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside
the upper range specified in the IMx HAVAB Package Insert.
VOLUME OF PRODUCT IN COMMERCE 397 kits.
DISTRIBUTION Nationwide, PR, Canada, Germany, and Thailand.
Unomedical, Inc. Issues Nationwide Public Safety Alert on Hospitak Airway Adapter
Unomedical, Inc. has issued a public safety alert regarding their Hospitak brand 22 mm /15mm airway adapter (Ref 962-E) distributed by Unomedical Inc., McAllen, Texas, because of safety concerns. The product is labeled as being manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico. Several adapters have been found to be blocked or occluded -- potentially preventing exhalation or inhalation. This could result in serious or life-threatening injury to patients
Although this product is primarily distributed to medical institutions, some units could be distributed for home use. These adapters are used as accessories in a wide variety of respiratory applications, for example: extending breathing circuits and attaching reservoir bags.
Hospitak brand 22 mm /15mm adapters were distributed to hospital and home health care supply distributors nationwide. Two lots have been identified as being potentially affected by the problem so far:
This investigation is continuing and other lot numbers may be involved. The adapter's package labeling can be identified by the Hospitak brand name and "REF 962-E." Patients and medical health professionals who have Hospitak adapters should check with Unomedical, Inc. before using the product to make sure it is not occluded. Unomedical can be reached at 1 800 634 6003. Those who have other questions or concerns may also contact their local FDA office. Unomedical, Inc. is working in cooperation with the FDA.
Nationwide Warning/Recall on Hospitak Airway Adapters Expands to other Lots and to Viasys, Dräger, and Unomedical Brand Airway Adapters
Unomedical Inc., of McAllen , Texas , announced today that it was expanding its warning and beginning a recall of airway adapters it distributed in the U.S. and Europe . Several adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation. This could result in serious or life-threatening injury to patients.
In a public alert issued on November 28, the company warned the public that at least two lots of its Hospitak brand 22mm/15mm adapters may have been affected by this problem. Although this product is primarily distributed to medical institutions, some units ma y be distributed for home use. These adapters are used in a wide variety of respiratory applications, for example: extending breathing circuits and attaching reservoir bags. Consumers who have one of these recalled products should stop using it, contact their physicians and contact Unomedical, Inc.
Subsequent investigation by the company indicates that other lots of the product, including airway adaptors used in other medical devices, may have been affected. Some of the affected products have been labeled and sold under the Viasys, Unomedical, and Dräger brand name. The total list of affected products and lot numbers are as follows. The lot number is displayed on the immediate label of the package.
Patients and medical health professionals who have Hospitak, Viasys, Unomedical, and/or Dräger brand airway adapters should check with Unomedical, Inc. before using the product. Patients and health care institutions who are not sure of the origin of the airway adapters they have in stock may want to check with their suppliers to make sure that they are not affected by this recall.
Patients and medical institutions may contact Unomedical at 1-800-634-6003.
Pulmonetic Systems, Inc. Issues Nationwide Recall of Cable Adaptors for Medical Ventilators
Pulmonetic Systems, Inc., is voluntarily initiating a recall of 1,129 Universal Cable Adaptors (adaptors) used to power medical ventilators, distributed between November 2 and November 8, 2004.
The affected adaptors, labeled as either Part No. 17765-001 or PN 17820-001, were intended as a permanent field correction to the November 1, 2004, voluntary Class I Recall for malfunction of certain ventilators. These ventilators malfunction when the external DC power source is inadequate, causing failure of the ventilator to breathe for the patient, and which could result in permanent neurological failure or death. The recall initiated by Pulmonetic Systems on November 1, 2004, applies to LTV® Series Ventilators manufactured prior to September 2003 with serial numbers less than:
LTV 1000- S# A06500
LTV 900- S# B03500
LTV 950- S# C07000
LTV 800- S# D01400
and which do not have the ♪ symbol displayed on the ventilator rear panel label. (Upper left or lower right of rear panel label) Please check all ventilators in your inventory/control to ensure all affected devices are identified.
The company has notified customers who have received adaptors by certified mail on December 1, 2004. They have been asked to remove the adaptors according to the instructions provided and return the adaptors to the company.
Interim Instructions when using affected ventilators without the adapter:
If you are using the ventilator on external battery or DC automobile power cable and the red VENT INOP alarm lights up and the alarm may sound, and the ventilator is not ventilating properly.
or
If you are using the ventilator on external battery or DC automobile power cable and the audible alarm may sound for 1 second duration every 3.5 seconds and the ventilator is not ventilating properly:
As part of ventilator patient care, caregivers should always be prepared to provide alternate means of ventilation should any product malfunction occur.
The firm voluntarily took this action and promptly notified FDA. The permanent correction to the power switchover malfunction identified in the November 1, 2004 recall will be to replace the ventilator power board for each of the affected devices, according to the company. Customers will be receiving instructions shortly on how to return any affected devices for a power board replacement at a Pulmonetic Systems authorized Service Center.
Users with questions should contact their healthcare providers.
Healthcare providers with questions should contact Pulmonetic Systems at 1-800-754-1914 extension 2.
Nationwide Voluntary Recall Issued for CARDIAC Reader™ System
Roche Diagnostics today announced a recall for the CARDIAC Reader™ system due to the potential that the system could start the measuring process before the user applies the sample. As a result, there is a potential for falsely decreased or false negative Troponin T results and falsely decreased Myoglobin results. These tests are used as part of the diagnostic process for myocardial infarction (heart attack).
This recall action does not affect Roche's Elecsys® Troponin T STAT reagent pack, Elecsys Myoglobin STAT reagent pack, or TROPT Sensitive Rapid assay strips.
Roche Diagnostics voluntarily initiated this recall action after reviewing practice patterns in the U.S. and is working directly with the U.S. Food and Drug Administration to ensure that all appropriate parties are notified. Laboratory customers who need to review the field correction action notice can do so by logging into their customer website at www.mylabonline.com.
Bio-Med Devices, Inc. Issues Nationwide Recall on Bio-Med Patient Tubing Assembly with Adaptor
Bio-Med Devices, Inc. of Madison, CT is voluntarily recalling Patient Breathing Circuits with Catalog Numbers: 80011, 80015, 8002A, 8002A-7, 8002A-9, DENTL, 3030-5, 4408 (built between September 22, 2004 and December 2, 2004, as indicated by last six digits of lot number MMDDYY). The device contains a 22mm x 22mm adapter made, and recalled, by Unomedical (of McAllen, TX), who has found a potential blockage problem (in a small percentage of parts of this type) which could contribute to serious or life threatening injury to patient. Our firm has not received any complaints or reports of adverse events.
The product is distributed to hospitals and through distributors nationwide.
Bio-Med has suspended sales until the company is certain that the affected product has been removed from distribution. Distributors and hospitals who have purchased the affected products are urged to return the product to Bio-Med Devices at 170 Fort Path Rd, Madison, CT 06437 for replacement.
Distributors and hospital personnel with questions may contact the company at (203) 458-020
WEEK ENDING DECEMBER 18
PRODUCT
IDEAL SOFT® (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate).
38% water immersed in 0.9% sodium chloride solution. One sterile.
CODE
Lot numbers: QG03, QG10, QG19, QH06, QH09, QH14, QI05, QI11, QI20, QJ14, QJ15,
QF27, QG29, QI25, QH08 QH22 & SF23.
RECALLING FIRM/MANUFACTURER
Ideal Optics, Inc, Atlanta, GA.
REASON
Lenses may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
1,764 vials.
DISTRIBUTION
AL, GA, NC, NY, SC, VA.
PRODUCT LifePort®, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter
Kit, Product Code/REF: LPS 7255. Catalog #LPS 7255m.
CODE
Kit # 20474.
RECALLING FIRM/MANUFACTURER
Horizon Medical Products, Inc., Manchester, GA.
REASON
The product has an incorrectly sized introducer included in the kit. The kit
contains a 12 French introducer instead of a 7 French introducer.
VOLUME OF PRODUCT IN COMMERCE
44 kits.
DISTRIBUTION
FL, GA, LA, MD, NJ, OK, TX and VA.
PRODUCT
Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT
and SDS-CTP-SPK.
CODE
Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October
2008.
RECALLING FIRM/MANUFACTURER
Medrad Inc., Indianola, PA.
REASON
Sterility can be compromised by a tear in the outer packaging.
VOLUME OF PRODUCT IN COMMERCE
875,798 kits.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Alsius CoolGard 3000 patient temperature regulation system.
CODE
Serial numbers 30000160 and 30000132.
RECALLING FIRM/MANUFACTURER
Alsius Corporation, Irvine, CA.
REASON
Product alarms that there may be a power supply interruption.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL and NC.
PRODUCT
XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated
nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without
coating (standard cover). Responsible firm on the label: Manufactured for
STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770.
The unit consists of a sleep surface, an integrated valve box located in the
head of the mattress, a pump box located under the foot of the mattress and
a color touch screen controller that can be mounted to either side of the
pump box at the foot end of the mattress.
CODE
The following serial numbers, which represent all units shipped: H40001 thru
H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013,
I40014, I40017, I40018, and I40021.
RECALLING FIRM/MANUFACTURER
Gaymar Industries, Inc, Orchard Park, NY.
REASON
Design control/validation deficiencies.
VOLUME OF PRODUCT IN COMMERCE
48 units.
DISTRIBUTION
NE and HI.
PRODUCT
AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract
of rabbit brain with buffer, stabilizers and calcium chloride.
CODE
Lot number M13906, Exp. 6/14/06.
RECALLING FIRM/MANUFACTURER
Trinity Biotech USA, Jamestown, NY.
REASON
Prolongation of Prothrombin times in patient samples, resulting in a falsely
elevated INR value.
VOLUME OF PRODUCT IN COMMERCE
1,183 kits.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465.
CODE
Part number: 465101 Lot Numbers - Date of Mfg - Expiration Date M310237 -
10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005 M403026 - 03/05/2004
- 03/31/2005 M406041 - 06/10/2004 - 06/30/2005.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA.
REASON
Beckman Coulter has confirmed that occasionally a cuvette may be skipped during
the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential
for carryover into the SYNCHRON Lipase (LIPA) assay, resulting in a substantial
positive bias affecting Lipase (LIPA) results.
VOLUME OF PRODUCT IN COMMERCE
6,698.
DISTRIBUTION
Nationwide and Canada.
PRODUCT Immulite 2500 Automated Immunoassay Analyzer, Homocysteine (HCY) test system.
CODE
Serial Number: B0071; B0095; B0055; B0060; B0124; B0131; B0097; B0106; B0064;
B0087; B0073; B0113; B0121; B0135; B0122; B0123; B0102.
RECALLING FIRM/MANUFACTURER
DPC Cirrus, Flanders, NJ.
REASON
Erroneous handling of samples will cause problems after the system is placed
in “Sample-pause”.
VOLUME OF PRODUCT IN COMMERCE
83 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
3M nexcare First Aid HoldFast Roll Gauze, Catalog number HF-2R. 1 Roll, 2
in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with
paper cover) contains no labeling.
CODE
Lot # 4267.
RECALLING FIRM/MANUFACTURER
3M Company/Medical Division, South St. Paul, MN.
REASON
Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product
is labeled with "Sterility Guaranteed Unless Package is Opened or Damaged".
VOLUME OF PRODUCT IN COMMERCE
3,528 rolls.
DISTRIBUTION
Nationwide and Guam.
PRODUCT
Access Immunoassay Systems, Discrete photometric chemistry analyzer.
CODE
Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1,
and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA.
REASON
A rare condition of the Access 2 Immunoassay Systems software versions 2.0,
2.1 and 2.2 could present a risk of an erroneous confirmatory result under
a specific set of circumstances. The Chlamydia Blocking results may be affected.
The instrument will erroneously perform the blocking calculation on the affected
test by using the mean of the diluted and neat results.
VOLUME OF PRODUCT IN COMMERCE
1,197 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
BD™ Phoenix™ ID/AST panels, catalog numbers 448007, 448008, 448400, 448452,
448459, 448600, and 448708, packaged in cartons of 25 panels.
CODE
Lots: 3316699 11/30/2004 4146868 05/31/2005 4063959 03/31/2005 4231466 08/31/2005
3288384 10/31/2004 3316697 11/30/2004 4035990 02/28/2005 4063276 03/31/2005
4133618 05/31/2005 4203249 07/31/2005 4209161 08/31/2005 4245919 09/30/2005
4231472 08/31/2005 4181008 07/31/2005 4224731 08/31/2005 4231473 08/31/2005
4224708 08/31/2005.
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Company, Sparks, MD.
REASON
The foil pouch containing an in vitro diagnostic test kit for bacteria identification
in patient samples may be defective and cause incorrect patient results.
VOLUME OF PRODUCT IN COMMERCE
1,250 cartons of 25 units/carton.
DISTRIBUTION
Nationwide.
PRODUCT
CXP software for Cytomics FC500 Cytometer.
CODE
Versions 1.0, 1.1, and 2.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA.
REASON
Incorrect sample identification can be displayed and printed on the Runtime
Panel Report due to a software defect.
VOLUME OF PRODUCT IN COMMERCE
167.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
DL2000 Data Manager Software, Version 6.4.108.
CODE
Version 6.4.108.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA.
REASON
Possibility of reporting an incorrect result occurs due to a software
anomally.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL, IL, and CA.
WEEK ENDING DECEMBER 25
PRODUCT
a) Hospitak, REF-903-GM, IPPB Circuit Exhalation
Valve & Nebulizer Circuit Universal 4î Length
with Adapter.
b) Hospitak, REF-903-E, IPPB Ventilator Circuit.
c) Hospitak, REF-1011, IPPB Ventilator Circuit.
d) Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10î.
e) Hospitak, REF CJ4N2Y-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12î.
f) Hospitak, REF CJ4N1VY-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12î.
g) Hospitak, REF 962-E, Adapter 22mm/15mm.
h) Hospitak, REF 1450, Face Ten Mask w/Aerosol
Tubing 60î, Oxygen Tubing 7î and Connector.
i) Hospitak, REF 8026, Adapter 22mm/15mm.
j) Viasys, REF BLD-14772, Pulmanex Adult
Transport Ventilator Circuit with Exhalation
Valve, Non-Heated, 72î.
k) Viasys, REF BLD-14660, Pulmanex Adult
Transport Circuit w/Exhalation Valve,
Non-Heated, 60î.
l) Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D.
x 22mm O.D. x 15mm I.D.
m) Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit:
Medium Adult.
n) Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit:
Large Adult.
o) Unomedical REF 962MM, Adapter 22mm/15mm.
p) Drager Medical, REF 40314160, Bird-Bennet-Monaghan
IPPB circuit, Latex Free.
CODE
a) Lot numbers 04-35 and 04-36;
b) Lot number 04-35;
c) Lot numbers 04-40 and 04-41;
d) Lot number 04-38;
e) Lot number 04-37;
f) Lot number 04-37;
g) Lot numbers 04-37, 04-38, 04-40, 04-41,
04-44, 04-45, 04-46, 04-47, and 04-48;
h) Lot numbers 04-42, 04-43, and 04-47;
i) Lot numbers 04-36, 04-37, and 04-47;
j) Lot numbers 23604005 and 31504003;
k) Lot number 31304004;
l) Lot numbers 27904001 and 29504001;
m) Lot numbers 28004002 and 29604001;
n) Lot number 29404003;
o) Lot numbers 04-35, 04-36, 04-37,
and 04-40.
p) Lot numbers 04-38 and 04-44.
RECALLING FIRM/MANUFACTURER Unomedical, Inc., McAllen, TX.
REASON
Adapters have been found to be blocked or occluded ‚ potentially preventing
exhalation or inhalation.
VOLUME OF PRODUCT IN COMMERCE
400,487 total adapters.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 800.
b) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 950.
c) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 900.
d) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 1000.
CODE
All Universal Cable Adapters identified on outer packaging as part no. 17820-001
and distributed between 11/02/04 and 11/08/04.
RECALLING FIRM/MANUFACTURER
Pulmonetic Systems, Inc., Minneapolis, MN.
REASON
The Universal Cable Adaptor, is not functioning as intended and/or the cable
is not securely attaching to the connection on the ventilator.
VOLUME OF PRODUCT IN COMMERCE
1,129 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1 1û2î
Needle Catalog Number: 4250.
b) Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1î
Needle Catalog Number: 4251.
c) Portex Hypodermic Needle-Pro 5 ml Syringe,
21g x 1 1û2î Needle Catalog Number: 4252.
d) Hypodermic Needle-Pro 5 ml Syringe, 21g x 1î
Needle Catatlog Number: 4253.
e) Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 1û2î
Needle Catalog Number: 4254.
f) Portex Pro-Vent Arterial Blood Sampling Kit with
Dry Lithium Heparin for Gases and Electrolytes
Catalog Number: 4589P-1.
g) Portex Tracheostomy Tube Decannulation Cap for
use only with Fenestrated Tracheostomy Tubes
Catalog Number: 519000.
h) Portex Tracheostomy Tube Decannulation Cap
for use only with Fenestrated Tracheostomy Tubes
Catalog Number: 519000.
i) Portex Lo-Profile Tracheostomy Tube Decannulation
Cap Catalog Number: 582000.
j) Portex Dual-Axis Swivel Adapter Catalog Number: 525151.
k) Portex PEEP-KEEP Dual-Axis SwivelAdapter
Catalog Number: 525351.
l) Portex Single Swivel Adapter Catalog Number: 525451.
m) Fiberoptic Bronchoscope Dual-Axis Swivel
Adapter Catalog Number: 625191.
n) Portex 3 Way Stopcock Catalog Number: T1102.
o) Portex 3 Way Stopcock Catalog Number: T1103.
p) Portex 3 Way Stopcock Catalog Number: T1202.
q) Portex 3 Way Stopcock Catalog Number: T1203.
r) Portex 4 Way ìT-Handleî Stopcock Catalog
Number: T1204.
s) Portex 4-Way Stopcock Catalog Number: T1206.
t) Portex ULTRA-FLO 4 - Way Stopcock Catalog
Number: T1209.
u) Portex ULTRA-FLO 4 ‚ Way Stopcock Catalog
Number: T1210.
v) Portex High Pressure 1-Way Stopcock Catalog
Number: T8200.
w) Portex High Pressure 4 - Way Stopcock Catalog
Number: T8202.
x) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1481.
y) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1483.
z) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1488.
aa) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1515.
bb) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1540.
cc) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1554.
dd) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1560.
ee) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1562.
ff) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1576.
gg) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1615.
hh) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1696.
ii) Portex 1-Way Stopcock Catalog Number: T1201.
CODE
a) Lot numbers starting with: 1, K1, K51, K52, K53;
b) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53;
c) Lot numbers starting with: K1, K2, K50, K51,
K52, K53 and 111381,111448, 111449;
d) Lot numbers starting with: K1, K53;
e) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53;
f) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53, K541, K542, K543;
h) Lot numbers starting with: 0, 1, 911, 912, K1,
K2, K50, K51, K52;
i) Lot numbers starting with: 1, K1, K2, K50;
j) Lot numbers starting with: 0, 1, 910, 912, K1,
K2, K50, K51, K52;
k) Lot numbers starting with: 0, 1, 912, K1, K2,
K50, K52;
l) Lot numbers starting with: 0, 1, K1, K2, K50,
K51;
m) Lot numbers starting with: 0, 1, 911, 912, K1,
K2, K50, K51, K52;
n) Lot numbers starting with: 0, 909, 911, K1,
K51, K52;
o) Lot numbers starting with: 1, K1;
p) Lot numbers starting with: 1, K1;
q) Lot numbers starting with: 0, 1, 911, 912, K1,
K2, K50, K51, K52;
r) Lot numbers starting with: 0, 1, 909, 911, 912,
K1;
s) Lot numbers starting with: 0, 1, 911, 912, K1,
K50, K52;
t) Lot numbers starting with: 0, 1, K1, K2, K51;
u) Lot numbers starting with: 0, 1, 909, 911, K1,
K50, K51;
v) Lot numbers starting with: 0;
w) Lot numbers starting with: 0, 1, K1, K2, K51,
K52;
x) Lot numbers starting with: 1, K1, K2, K50, K51;
y) Lot numbers starting with: 1, K1, K52;
z) Lot numbers starting with: 1, K1, K2, K51, K53;
aa) Lot numbers starting with: 1, K1, K2, K540;
bb) Lot number 110727;
cc) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53;
dd) Lot numbers starting with: 1, K1, K2, K50,
K51, K52, K53;
ee) Lot numbers starting with: 1, K1, K50, K51,
K541;
ff) Lot numbers starting with: K1, K2, K51;
gg) Lot numbers starting with: 1, K1, K2, K51;
hh) Lot number: K513947;
ii) Lot Numbers starting with: 0,K1, K2.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH.
REASON
Sterility of the device is compromised due to packaging defects.
VOLUME OF PRODUCT IN COMMERCE
909,546 units.
DISTRIBUTION
Nationwide.
PRODUCT
Magnetic Resonance Imaging Systems under the following names: Visart, Excelart,
Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc., Tustin, CA.
REASON
Software defect causes images to be rotated 180 degrees.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide.
PRODUCT
Linear Array Transducer Type: 8809.
CODE
Serial Numbers: 1831984, 1831985, 1831986, 1831987, 1831989, 1831990, 1831992,
1832004, 1832007, 1844219, 1844235, 1844239, 1844240, 1844241, 1847871, 1847875,
1847889.
RECALLING FIRM/MANUFACTURER
B & K Medical Systems Inc., North Billerica, MA.
REASON
Defect at probe tip may affect sterilization and electrical safety.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
Nationwide.
PRODUCT
Magnetic Resonance Imaging Systems, under the following names: Visart Excelart
P2 Excelart P3 Excelart SPIN.
CODE
No specific codes were listed.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc, Tustin, CA.
REASON
Software defect causes patient identification number to be truncated.
VOLUME OF PRODUCT IN COMMERCE
39
DISTRIBUTION
Nationwide.
PRODUCT
Baxter System 1000 Single Patient Hemodialysis Delivery System, Model SYS1000;
all series 1000 instruments labeled as System 1000. AltraTouch 1000, Baxter
Tina and Baxter Aurora;
CODE
All system 1000 units with serial numbers prior to 22224.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Deerfield, IL.
REASON
The air detector may not detect air bubbles consistently at the selected limit.
VOLUME OF PRODUCT IN COMMERCE
28,482 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) OTC Pregnancy Tests. Name: Sure Check hCG
Midstream Pregnancy Test --- Description:
the Sure Check hCG Midstream Pregnancy test
consists of a lateral flow membrane pad
containing anti-’ hCG monoclonal antibody
conjugated to colloidal gold contained in a
plastic ìwandî with an absorbent wick at
one end. Catalog numbers are solely used for
ordering by the different distributors.
This OTC product is shipped as either bulk
packaged product or as private labeled
material labeled as follows:
SURE CHECKô ONE STEP Pregnancy Test ---
1 TEST; UPC 6 07158 00110 3; Catalog
# PT110SURE/12.
SURE CHECKô ONE STEP Pregnancy Test ---
2 TESTS; UPC 6 07158 00112 7; Catalog #
PT112/24.
exactô pregnancy test. UPC 0 60383 66207 3;
Catalog # PT110-N4 (Neuco).
exactô pregnancy test --- 2 tests;
UPC 0 60383 68179; Catalog # PT112-N4 (Neuco).
OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY
TEST (TEST DE GROSSESSE EN UNE ETAPE) ---
1 TEST --- UPC 0 61925 57608; Catalog #
PT110-N7 (Neuco).
BODY BASICSô Pregnancy Test (Test de grossesse)
--- 1 Test --- UPC 0 57627 71110 9;
Catalog # PT110-N6/12 (Neuco)
Option+ TEST DE GROSSESSE UNE ETAPE/ONE
STEP PREGNANCY TEST - UPC 7 71290 05402 7;
Catalog # PT110-N2 (Neuco). True-Testô Pregnancy Test Kit (Examen del
Embarazo) One Step Testing
1 Test - UPC 0 61406 37505 5;
Catalog # PT110-R1 (Ultras).
Shaw's ONE-STEP Pregnancy Test -1 TEST
Made in USA; UPC 0 45674 65589 7;
Catalog # PT110-S1.
Harris Teeter Pregnancy Test Kits One Step ‚
Easy to use Pregnancy Test Kit ---
Two Home Test Kits -UPC 0 72036 72061 0;
Catalog # PT112-R2 (Harris Teeter).
Bulk packaged product is assigned
Catalog # PT110, with varying quantities
510(k) K961965.
b) OTC Pregnancy Tests. Name: Sure Check hCG
Cassette Pregnancy Test. --- Description:
the Sure Check hCG Cassette Pregnancy test
consists of a lateral flow membrane pad
containing anti-’ hCG monoclonal antibody
conjugated to colloidal gold contained in
a plastic cassette. It differs from the
Sure Check Midstream product in that the
lateral flow membrane pad is placed in a
cassette and the urine sample is added by
pipette rather than by urinating on the
absorbent wick. The device is packaged in
a foil pouch with desiccant. This product
is shipped as bulk packaged product of
varying quantities (Catalog # PT127-OTC;
Catalog # PT210 ordered by LABSCO).
510(k) K933529/A.
CODE
a) Lot U030504 (Exp. 30 AUG 06).
Recall Expansion: lots U032904 (Exp. 31 AUG 06),
U060804 (Exp. 30 NOV 06),
U040104 (Exp. 30 SEP 06),
U040904/1 (Exp. 30 SEP 06);
b) Lot U040904 (Exp. 30 SEP),
Recall Expansion: lot U032904/1 (Exp. 30 AUG 06).
RECALLING FIRM/MANUFACTURER
Chembio Diagnostic System Inc., Medford, NY.
REASON
Poor sealing of pouches and degradation of products. Investigation revealed
invalid results (no control lines) and some false negatives.
VOLUME OF PRODUCT IN COMMERCE 359,610 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Medtronic Midas Rex Legend High Speed Pneumatic System.
CODE
Serial Numbers: A0046-V02 ; A0079-V01 ; A0089-V01 ; A0091-V01 ; A0096-V02 ;
A0106-V02 ; A0233-V02 ; A0235-V02 ; A0249-V01 ; A0251-V01 ; A0259-V01 ; A0260-V02
; A0261-V02 ; A0264-V01 ; A0271-V02 ; A0272-V02 ; A0274-V02 ; A0275-V02 ; A0281-V02
; A0406-V02 ; A0422-V01 ; A0424-V01 ; A0426-V01 ; A0444-V01 ; A0448-V01 ; A0453-V02
; A0454-V02 ; A0456-V02 ; A0535-V02 ; A0693-V01 ; A0697-V01 ; A0698-V01 ; A0699-V01
; A0710-V02 ; A0717-V02 ; A0725-V02 ; A0726-V02 ; A0735-V02 ; A0736-V02 ; A0744-V02
; A0750-V02 ; A0761-V02 ; A0837-V01 ; A0838-V01 ; A0854-V01 ; A0855-V01 ; A0863-V02
; A1008-V02 ; A1079-V02 ; A1081-V02 ; A1082-V02 ; A1083-V02 ; A1084-V02 ; A1114-V02
; A1136-V01 ; A1137-V01 ; A1138-V01 ; A1145-V01 ; A1147-V01 ; A1148-V01 ; A1300-V02
; A1304-V02 ; A1341-V02 ; A1342-V02 ; A1391-V02 ; A1393-V02 ; A1467-V02 ; A1475-V01
; A1499-V02 ; A1533-V02 ; A1535-V02 ; A1545-V02 ; A1659-V02 ; A1660-V02 ; A2031-V01
; A2169-V01 ; A2309-V02 ; A2310-V02 ; A2312-V02 ; A2314-V02 ; A2316-V02 ; A2318-V02
; A2321-V02 ; A2322-V02 ; A2325-V02 ; A2342-V01 ; A2344-V01 ; A2346-V01 ; A2356-V01
; A2363-V01 ; a2366-v01 ; A3195-V02 ; A3368-V02 ; A3374-V01 ; A3671-V02 ; A3683-V02
; A3692-V01 ; A3927-V02 ; A3985-V02 ; A3996-V01 ; A4244-V01 ; A4300-V02 ; A4340-V01
; A4635-V02 ; A4700-V02 ; A4712-V02 ; A4718-V02 ; A4721-V02 ; A4722-V02 ; A4725-V02
; A4731-V02 ; A5263-V01 ; A5270-V01 ; A5271-V01 ; A5368-V01 ; A5375-V01 ; A5539-V01
; A5540-V01 ; A5541-V01 ; A5547-V01 ; A5553-V01 ; A5558-V01 ; A5563-V02 ; A5900-V01
; A5902-V01 ; A5903-V01 ; A5904-V01 ; A5906-V01 ; A5908-V01 ; A5909-V01 ; A5910-V01
; A5912-V01 ; A5913-V01 ; A5914-V01 ; A5920-V02 ; A5923-V02 ; A5923-VO2 A5924-V02: A5925-V02 ; A5926-V02 ; A5927-V02 ; A5928-V02 ; A5929-V02 ; A5935-V02 ; A5936-V02
; A5939-V02 ; A5940-V02 ; A5941-V02 ; A5943-V02 ; A5944-V02 ; A5945-V02 ; A5948-V02
; A5949-V02 ; A5952-V02 ; A5955-V02 ; A5956-V02 ; A5957-V02 ; A5959-V02 ; A6034-V02
; A6035-V02 ; A6036-V02 ; A6037-V02 ; A6038-V02 ; A6039-V02 ; A6040-V02 ; A6041-V02
; A6042-V02 ; A6043-V02 ; A6044-V02 ; A6048-V02 ; A6049-V02 ; A6050-V02 ; A6051-V02
; A6052-V02 ; A6054-V01 ; A6055-V01 ; A6056-V01 ; A6057-V01 ; A6058-V01 ; A6059-V01
; A6060-V01 ; A6061-V01 ; A6062-V01 ; A6066-V01 ; A6067-V01 ; A6068-V01 ; A6069-V01
; A6070-V01 ; A6071-V01 ; A6072-V01 ; A6073-V02 ; A6075-V02 ; A6077-V02 ; A6078-V02
; A6079-V02 ; A6080-V02 ; A6082-V02 ; A6235-V02 ; A6236-V02 ; A6237-V02 ; A6239-V02
; A6240-V02 ; A6241-V02 ; A6242-V02 ; A6243-V02 ; A6245-V02 ; A6247-V02 ; A6248-V02
; A6250-V02 ; A6251-V02 ; A6252-V02 ; A6253-V02 ; A6256-V01 ; A6257-V01 ; A6258-V01
; A6259-V01 ; A6260-V01 ; A6262-V01 ; A6264-V01 ; A6266-V01 ; A6267-V01 ; A6269-V01
; A6271-V01 ; A6272-V01 ; A6273-V01 ; A6435-V02 ; A6436-V02 ; A6441-V01 ; A6442-V01
; A6443-V01 ; A6444-V01 ; A6448-V01 ; A6450-V01 ; A6453-V01 ; A6455-V01 ; A6459-V01
; A6475-V02 ; A6476-V02 ; A6477-V02 ; A6479-V02 ; A6480-V02 ; A6481-V02 ; A6483-V02
; A6484-V02 ; A6486-V02 ; A6487-V02 ; A6488-V02 ; A6489-V02 ; A6490-V02 ; A6491-V02
; A6492-V02 ; A6493-V02 ; A6494-V02 ; A6497-V02 ; A6498-V02 ; A6499-V02 ; A6500-V02
; A6502-V02 ; A6509-V02 ; A6515-V02 ; A6516-V02 ; A6517-V02 ; A6518-V02 ; A6726-V01
; A6729-V01 ; A6736-V01 ; A6741-V01 ; A6742-V01 ; A6743-V01 ; A6744-V01 ; A6745-V01
; A6746-V01 ; A6747-V01 ; A6748-V01 ; A6749-V01 ; A6750-V01 ; A6751-V01 ; A6752-V01
; A6753-V01 ; A6754-V01 ; A6880-V01 ; A6882-V01 ; A6883-V01 ; A6884-V01 ; A6886-V01
; A6888-V01 ; A6892-V01 ; A6893-V01 ; A6894-V01 ; A6895-V01 ; A6896-V01 ; A7074-V01
; A7075-V01 ; A7076-V01 ; A7077-V01 ; A7078-V01 ; A7079-V01 ; A7080-V01 ; A7081-V01
; A7082-V01 ; A7083-V01 ; A7113-V02 ; A7114-V02 ; A7115-V02 ; A7117-V02 ; A7118-V02
; A7119-V02 ; A7120-V02 ; A7121-V02 ; A7122-V02 ; A7123-V02 ; A7124-V02 ; A7127-V02
; A7128-V02 ; A7129-V02 ; A7130-V02 ; A7131-V02 ; A7132-V02 ; A7134-V02 ; A7136-V02
; A7142-V02 ; A7384-V01 ; A7385-V01 ; A7386-V01 ; A7388-V01 ; A7389-V01 ; A7390-V01
; A7391-V01 ; A7392-V01 ; A7393-V01 ; A7394-V01 ; A7395-V01 ; A7397-V01 ; A7398-V01
; A7399-V01 ; A7401-V01 ; A7402-V01 ; A7403-V01 ; A7404-V01 ; A7405-V01 ; A7407-V01
; A7411-V01 ; A7415-V01 ; A7416-V01 ; A7417-V01 ; A7418-V01 ; A7419-V01 ; A7421-V01
; A7422-V01 ; A7423-V01 ; A7424-V01 ; A7425-V01 ; A7427-V01 ; A7436-V02 ; A7440-V02
; A7441-V02 ; A7444-V02 ; A7445-V02 ; A7446-V02 ; A7447-V02 ; A7448-V02 ; A7449-V02
; A7453-V02 ; A7454-V02 ; A7455-V02 ; A7462-V02 ; A7469-V02 ; A7470-V02 ; A7471-V02
; A7474-V02 ; A7475-V02 ; A7476-V02 ; A7477-V02 ; A7478-V02 ; A7479-V02 ; A7480-V02
; A7481-V02 ; A7482-V02 ; A7483-V02 ; A7871-V01 ; A7961-V02 ; A7962-V02 ; A7963-V02
; A7964-V02 ; A7965-V02 ; A7966-V02 ; A7967-V02 ; A7968-V02 ; A7969-V02 ; A7970-V02
; A7981-V02 ; A7982-V02 ; A7983-V02 ; A7984-V02 ; A7985-V02 ; A7986-V02 ; A7987-V02
; A7988-V02 ; A7989-V02 ; A7990-V02 ; B0019-V02 ; B0020-V02 ; B0027-V02 ; B0032-V02
; B0033-V02 ; B0034-V02 ; B0037-V02 ; B0038-V02 ; B0044-V02 ; B0046-V02 ; B0047-V02
; B0048-V02 ; B0051-V02 ; B0058-V02 ; B0060-V02 ; B0064-V02 ; B0066-V02 ; B0071-V02
; B0072-V02 ; B0074-V02 ; B0079-V02 ; B0092-V02 ; B0102-V02 ; B0108-V02 ; B0111-V02
; B0114-V02 ; B0121-V02 ; B0122-V02 ; B0133-V02 ; B0137-V02 ; B0166-V02 ; B0179-V02
; B0225-V02 ; B0248-V01 ; B0283-V01 ; B0297-V02 ; B0298-V02 ; B0300-V02 ; B0301-V02
; B0302-V02 ; B0303-V02 ; B0305-V02 ; B0306-V02 ; B0308-V02 ; B0315-V02 ; B0316-V02
; B0319 ; B0320-V02 ; B0321-V02 ; B0325-V02 ; R8002-V01 ; T0088-V01 ; T0236-V02
; T0400 ; T0447-V02 ; T0458 ; T0461-V02 ; T0465-V01 ; T0486 ; T0490-V02 ; T0500-V02
; T0505-V02 ; T0514-V02 ; T0615-V01 ; T0619-V01 ; T0620 ; T0681-V02 ; T0687-V02
; T0688-V02 ; T0699-V02 ; t0706 ; T073 ; T0753 ; T0756-V01 ; T0972-V02 ; T0995-V01
; T1012-V02 ; T1020-V02 ; T1021-V02 ; T1133-V02 ; T1137 T1159-V01 ; T1257-V02
; T1259-V02 ; T1299-V02 ; T1315-V01 ; T1318 V)1 ; T1322-V01 ; T1332-V01 ; T1337-V01
; T1364-V02 ; T1368-V02 ; T1372-V01 ; T1375-V02 ; T1381-V02 ; T1391-V02 ; T1392-V02
; T1414-V01 ; T1433-V01 ; T1434-V01 ; T1435-V01 ; T1462-V02 ; T1525-V02 ; T1541-V01
; T1548-V01 ; T1549-V01 ; T1550-V01 ; T1559-V01 ; T1573-V02 ; T1579-V02 ; T1580
; T1603-V02 ; T1604-VO2 ; T1606-V02 ; T1625-V02 ; T1636-V01 ; T1639-V01 ; T1642
; T1651 ; T1654 ; T1669-V01 ; T1696-v02 ; T1697 ; T1699 ; T1702-V02 ; T1705-V02
; T1715-V02 ; T1717-V02 ; T1719-V02 ; T1727-V02 ; T1729-V02 ; T1737-V02 ; T1738-V02
; T1755 ; T1760-V02 ; T1766-V02 ; T1772-V02 ; T1818-V01 ; T1827-V01 ; T1832
; T1835-V01 ; T1918-V02 ; T1924-V02 ; T1947-V02 ; T1955-V02 ; T1957-V02 ; T1961-V02
; T1963-V02 ; T1965-V02 ; T1966-V02 ; T1969-V02 ; T1971-V02 ; T1973-V02 ; T1975-V02
; T1979-V02 ; T1999-V01 ; T2004-V01 ; T2016-V01 ; T2019-V01 ; T2027-V01 ; T2031-V01
; T2056-V02 ; T2057-V02 ; T2060-V02 ; T2063-V02 ; T2069-V01 ; T2070-V02 ; T2071-V01
; T2077-V01 ; T2079-V01 ; T2083-V01 ; T2087-V01 ; T2090-V01 ; T2095-V01 ; T2100-V01
; T2164-V02 ; T2166-V02 ; T2167-V02 ; T2168-V02 ; T2170-V02 ; T2175-V02 ; T2181-V02
; T2182-V02 ; T2183-V02 ; T2185-V02 ; T2187-V02 ; T2205-V02 ; T2208-V02 ; T2211-V02
; T2276-V02 ; T2301-V02 ; T2343-V02 ; T2362-V01 ; T2368-V01 ; T2385-V01 ; T2395-V01
; T2401-V01 ; T2408 ; T2415-V02 ; T2418-V02 ; T2421-V02 ; T2424-V02 ; T2431-V02
; T2437-V02 ; T2447-V02 ; T2457-V02 ; T2461-V02 ; T2464-V02 ; T2476-V01 ; T2480-V01
; T2484-V01 ; t2485-v01 ; T2487-V01 ; T2522-V01 ; T2523-V01 ; T2528-V01 ; T2529
; T2530 ; T2533-V01 ; T2534-V01 ; T2540-V01 ; T2541-V01 ; T2545-V01 ; T2674-V02
; T2675-V02 ; T2678-V02 ; T2686-V02 ; T2690-V02 ; T2698-V02 ; T2703-V02 ; T2710-V02
; T2723-V02 ; T2726-V02 ; T2774-V02 ; T2794-V02 ; T2830-V02 ; T2833-V02 ; T2885-V02
; T2887-V02 ; T2889-V02 ; T2892-V02 ; T2920-V01 ; T2939-V01 ; T2940 ; T2941-V01
; T2947-V01 ; T2960-V01 ; T2963 ; T2968-V01 ; T2969-V02 ; T2970-V01 ; T2971-V01
; T2972-V01 ; T2977-V01 ; T2983-V01 ; T2984-V01 ; T3017-V02 ; T3028-V02 ; T3033-V02
; T3036-V02 ; T3042-V02 ; T3047-V02 ; T3050-V02 ; T3051-V02 ; T3058-V02 ; T3059-V02
; T3061-V02 ; T3068-V02 ; T3073-V02 ; T3075-V02 ; T3076-V02 ; T3081-V02 ; T3086-V02
; T3089-V02 ; T3310-V01 ; T3324-V01 ; T3328-V01 ; T3352-V02 ; T3357-V02 ; T3360-V02
; T3363-V02 ; T3366-V02 ; T3376-V02 ; T3384-V02 ; T3387-0-V02 ; T3388-V02 ;
T3391-V02 ; T3393-V02 ; T3394-V02 ; T3400-V02 ; T3601-V01 ; T3606-V01 ; T3617-V01
; T3619-V01 ; T3630-V02 ; T3635-V02 ; T3639-V02 ; T3645-V02 ; T3651-V02 ; T3655-V02
; T3659-V02 ; T3662-V02 ; T3794-V02 ; T3799-V02 ; T3801-V02 ; T3808-V02 ; T3809-V02
; T3821-V02 ; T3829-V02 ; T3831-V02 ; T4003 ; T4007-V01 ; T4015-V01 ; T4016-V01
; T4019-V01 ; T4021-V01 ; T4050-V02 ; t4053-v02 ; T4058-V02 ; T4062-V02 ; T4070-V02
; T4078-V02 ; T4133-V02 ; T4134-V02 ; T4139-V02 ; T4141-V01 ; T4143-V02 ; T4147-V02
; T4148-V02 ; T4150-V02 ; T4152-V02 ; T4155-V02 ; t4161 ; T4163-V02 ; T4165-V02
; T4169-V02 ; T4173-V02 ; T4190-V02 ; T4359-V01 ; T4361-V01 ; T4369-V01 ; T4370
; T4385-V01 ; T4388-V01 ; T4395-V01 ; T4396-V01 ; T4397-V01 ; T4460-V02 ; T4464-V02
; T4469-V02 ; T4476-V02 ; T4479-V01 ; t4513 ; T4530-V02 ; T4538 ; T4543-VO2
; T4547-V02 ; T4551-V02 ; T4552-V02 ; T4554-V02 ; T4561-V02 ; T4567-V02 ; T4575-V02
; T4599-V02 ; T4604-V02 ; T4607-V02 ; T4609-V02 ; T4681-V01 ; T4683-V01 ; T4692-V01
; T4693-V01 ; T4694-V01 ; T4697-V01 ; T4700-V01 ; T4704-V01 ; T4773-V01 ; T4776-V01
; T4778-V01 ; T4779-V01 ; T4782-V01 ; T4793-V01 ; T4794-V01 ; T4802-V01 ; T4805-V01
; T5220 ; T5224 ; T5227-V02 ; T5228-V02 ; T5241-V02 ; T5244-V02 ; T5253-V02
; T5261-V02 ; T5276-V02 ; T5277-V02 ; T5283-V02 ; T5287-V02 ; T5289-V02 ; T5290-V02
; T5293-V02 ; T5295-V02 ; T5300-V02 ; T5302-V02 ; T5303-V02 ; T5317-V02 ; T5324-V02
; T5327-V02 ; T5330-V02 ; T5332-V02 ; T5334-V02 ; T5335-V02 ; T5337-V02 ; T5350-V02
; T5359 ; T5376-V02 ; T5378-V02 ; T5380-V02 ; T5384-V02 ; T5389-V02 ; T5396-V01
; T5397-V01 ; T5398-V01 ; T5400-V01 ; T5401-V01 ; T5402-V01 ; T5406-V01 ; T5427-V01
; T5433-V01 ; T5440-V01 ; T5441-V01 ; T5443-V01 ; T5445-V01 ; T5447-V01 ; T5448-V01
; T5453-V01 ; T5547-V02 ; T5556-V02 ; T5558-V02 ; T5564VO2 ; T5704-V02 ; T5709-V02
; T5710-V02 ; T5711-V02 ; T5713-V02 ; T5714-V02 ; T57152-V02 ; T5718-V02 ; T5729-V02
; T5730-V02 ; T5733-V02 ; T5737-V02 ; T5747-V02 ; T5749-V02 ; T5750-V02 ; T5752-V02
; T5753-V02 ; T5756-V02 ; T5757-V02 ; T6007-V01 ; T600-V02 ; T6020-V01 ; T6026
; T6027-V01 ; T6046-V02 ; T6050-V02 ; T6067-V02 ; T6077-V02 ; T6079-V02 ; T6081-V02
; T6145-V01 ; T6159-V01 ; T6188-V02 ; T6193-V02 ; T6196-V02 ; T6198-V02 ; T6205-V02
; T6211-V02 ; T6215-V02 ; T6216-V02 ; T6226-V02 ; T6235 ; T6241-V02 ; T6286-V01
; T6292-V01 ; T6293-V01 ; T6302-V01 ; T6303-V01 ; T6307-V02 ; T6309-V02 ; T6315-V02
; T6318-V02 ; T6321-V02 ; T6322-V02 ; T6325-V02 ; T6326-V02 ; T6327-V02 ; T6354-V02
; T6420-V01 ; T6426-V01 ; T6439-V01 ; T6442-V01 ; T6447-V02 ; T6451-V02 ; T6455-V02
; T6468-V02 ; T6473-V02 ; T6474-V02 ; T6488-V02 ; T6490-V02 ; T6496-V02 ; T6507-V02
; T6508-V02 ; T6513-V02 ; T6667-V02 ; T6668-V02 ; T6669-V02 ; T6672-V02 ; T6676-V02
; T6684-V02 ; T6685-V02 ; T6701-V02 ; T6704-V02 ; T6706-V02 ; T6770-V01 ; T6771-V01
; T6799-V01 ; T6816-V02 ; T6827-V01 ; T6830-V01 ; T6833-V01 ; T6836-V01 ; T6843-V01
; T6844-V01 ; T6881-V01 ; T6882-V01 ; T6884-V01 ; T6886 ; T6886-V01 ; T6892-V01
; T6893-V01 ; T6906-V01 ; T6911-V01 ; T6921-V01 ; T6925-V01 ; T6927-V01 ; T6928-V01
; T6933-V02 ; T6939-V02 ; T6941-V02 ; T6943-V02 ; T6947-V02 ; T6958-V02 ; T7001-V02
; T7017-V02 ; T7021-V01 ; T7024 ; T7031-V01 ; T7032-V01 ; T7038-V01 ; T7058-V01
; T7062-V01 ; T7063-V01 ; T7064-V01 ; T7074-V01 ; T7082-V02 ; T7085-V02 ; T7086-V02
; T7088-V02 ; T7094-V02 ; T7168-V01 ; T7170-V01 ; T7172-V01 ; T7174-V01 ; T7256-V02
; T7257-V02 ; T7262-V02 ; T7268-V02 ; T7275-V02 ; T7288-V02 ; T7289-V02 ; T7291-V02
; T7292-V02 ; T7293-V02 ; T7298-V02 ; T7305-V02 ; T7312-V02 ; T7314-V02 ; T7316-V02
; T7328-V01 ; T7335-V01 ; T7338-V01 ; T7340-V01 ; T7347-V01 ; T7513-V02 ; T7514-V02
; T7518-V02 ; T7520-V02 ; T7523-V02 ; T7525-V02 ; T7682-V02 ; T7754-V01 ; T7757-V01
; T7758-V01 ; T7762-V01 ; T7766-V01 ; T7767-V01 ; T7780-V02 ; T7785-V02 ; T7787-V02
; T7790-V02 ; T7793-V02 ; T7795-V02 ; T7801-V02 ; T7819-V01 ; T7823-V01 ; T7827-V01
; T7836-V02 ; T7842 ; T7888-V02 ; T7890-V02 ; T7903-V02 ; T7927-V01 ; T7933-V01
; T7937-V01 ; T7938-V01 ; T7940-V01 ; T7942-V01 ; T7944-V01 ; T7988-V01 ; T7989-V01
; T7991-V01 ; T7999-V01 ; T8019-V02 ; T8023-V02 ; T8024-V02 ; T8030-V01 ; T8045-V01
; T8098-V01 ; T8110-V01 ; T8114-V01 ; T8116-V01 ; T8123-V02 ; T8133-V02 ; T8141-V02
; T8143-V02 ; T8147-V02 ; T8151-V02 ; T8154-V02 ; T8155-V02 ; T8159-V02 ; T8160-V01
; T8161-V02 ; T8162-V02 ; T8175-V02 ; T8261-V02 ; T8273-V01 ; T8276-V01 ; T8277-V01
; T8280-V01 ; T8281-V01 ; T8283-V01 ; T8285-V01 ; T8286-V01 ; T8289-V01 ; T8291-V01
; T8297-V02 ; T8299-V02 ; T8304-V02 ; T8305-V02 ; T8309-V02 ; T8310-V02 ; T8312-V02
; T8313-V02 ; T8389-V01 ; T8390-V01 ; T8392-V01 ; T8398-V01 ; T8403-V02 ; T8409-V02
; T8410-V02 ; T8413-V02 ; T8416-V02 ; T8417-V02 ; T8418-V02 ; T8422-V02 ; T8425-V02
; T8426-V01 ; T8428-V02 ; T8432-V02 ; T8434-V02 ; T8442-V02 ; T8456-V01 ; T8460-V01
; T8462-V01 ; T8466-V01 ; T8472-V01 ; T8473-V01 ; T8497-V02 ; T8517-V02 ; T8518-V02
; T8578-V02 ; T8581-V02 ; T8590-V02 ; T8600-V01 ; T8603-V01 ; T8605-V01 ; T8606-V01
; T8612-V01 ; T8660-V02 ; T8662-V02 ; T8675-V02 ; T8682-V01 ; T8685-V01 ; T8688-V01
; T8689-V01 ; T8692-V01 ; T8693-V01 ; T8713-V02 ; T8715-V02 ; T8716-V02 ; T8730-V02
; T8732-V02 ; T8734-VO2 ; T8736-V02 ; T8738-V02 ; T8746-V01 ; T8758-V01 ; T8763-V01
; T8764-V01 ; T8770-V01 ; T8798-V01 ; T8869-V01 ; T8870-V01 ; T8876-V02 ; T8881-V02
; T8933 ; T9193-V01 ; T9279-V01 ; T9291-V02 ; T9293-V02 ; T9304-V01 ; T9315-V01
; T9324-V02 ; T9340-V02 ; T9343-V02 ; T9350-V02 ; T9354-V02 ; T9549-V02 ; T9562-V02
; T9575-V02 ; T9578-V02 ; T9585-V02 ; T9588-V02 ; T9593-V01 ; T9600-V01 ; T9604-V01
; T9726-V02 ; T9730-V02 ; T9731-V02 ; T9736-V02 ; T9739-V02 ; T9743-V02 ; T9744-V02
; T9773-V02 ; T9778-V02 ; T9882-V02 ; T9885-V02 ; T9910-V01 ; T9917-V01 ; T9953-V02
; A0087-V01 ; A0236-V01 ; A0401-V02 ; A0408-V02 ; A0425-V01 ; A0463-V02 ; A1305-V02
; A1345-V02 ; A1649-V02 ; A2032-V01 ; A2462-V02 ; a2465-v01 ; A278-V01 ; A3178-V02
; A3375-V01 ; A3992-V01 ; A4589-V02 ; A4652-V02 ; A4719-V02 ; A4720-V02 ; A4724-V02
; A4728-V02 ; A4730-V02 ; A4733-V02 ; A5905-V01 ; A5907-V01 ; A5911-V01 ; A5921-V02
; A5922-V02 ; A5930-V02 ; A5931-V02 ; A5932-V02 ; A5933-V02 ; A5934-V02 ; A5937-V02
; A5938-V02 ; A5942-V02 ; A5946-V02 ; A5950-V02 ; A5951-V02 ; A5953-V02 ; A5954-V02
; A5958-V02 ; A6033-V02 ; A6045-V02 ; A6046-V02 ; A6047-V02 ; A6065-V01 ; A6074-V02
; A6076-V02 ; A6081-V02 ; A6238-V02 ; A6244-V02 ; A6246-V02 ; A6249-V02 ; A6254-V02
; A6261-V01 ; A6263-V01 ; A6265-V01 ; A6268-V01 ; A6270-V01 ; A6427-V02 ; A6428-V02
; A6429-V02 ; A6430-V02 ; A6431-V02 ; A6432-V02 ; A6445-V01 ; A6446-V01 ; A6447-V01
; A6449-V01 ; A6451-V01 ; A6452-V01 ; A6454-V01 ; A6456-V01 ; A6457-V01 ; A6458-V01
; A6460-V01 ; A6478-V02 ; A6482-V02 ; A6485-V02 ; A6495-V02 ; A6496-V02 ; A6501-V02
; A6503-V02 ; A6504-V02 ; A6505-V02 ; A6506-V02 ; A6507-V02 ; A6508-V02 ; A6510-V02
; A6511-V02 ; A6512-V02 ; A6513-V02 ; A6514-V02 ; A6519-V02 ; A6520-V02 ; A6521-V02
; A6522-V02 ; A6523-V02 ; A6524-V02 ; A6725-V01 ; A6727-V01 ; A6728-V01 ; A6730-V01
; A6731-V01 ; A6732-V01 ; A6733-V01 ; A6734-V01 ; A6735-V01 ; A6737-V01 ; A6738-V01
; A6739-V01 ; A6740-V01 ; A6877-V01 ; A6878-V01 ; A6879-V01 ; A6881-V01 ; A6885-V01
; A6887-V01 ; A6889-V01 ; A6890-V01 ; A6891-V01 ; A7116-V02 ; A7125-V02 ; A7126-V02
; A7133-V02 ; A7135-V02 ; A7137-V02 ; A7138-V02 ; A7139-V02 ; A7140-V02 ; A7141-V02
; A7175-V01 ; A7176-V01 ; A7177-V01 ; A7178-V01 ; A7179-V01 ; A7180-V01 ; A7181-V01
; A7182-V01 ; A7387-V01 ; A7396-V01 ; A7400-V01 ; A7406-V01 ; A7408-V01 ; A7409-V01
; A7410-V01 ; A7414-V01 ; A7420-V01 ; A7426-V01 ; A7428-V01 ; A7429-V01 ; A7430-V01
; A7431-V01 ; A7432-V01 ; A7433-V01 ; A7434-V02 ; A7435-V02 ; A7437-V02 ; A7438-V02
; A7439-V02 ; A7442-V02 ; A7443-V02 ; A7450-V02 ; A7451-V02 ; A7452-V02 ; A7456-V02
; A7457-V02 ; A7458-V02 ; A7459-V02 ; A7460-V02 ; A7461-V02 ; A7463-V02 ; A7464-V02
; A7465-V02 ; A7466-V02 ; A7467-V02 ; A7468-V02 ; A7472-V02 ; A7473-V02 ; A7868-V01
; A7869-V01 ; A7875-V01 ; A7876-V01 ; A7877-V01 ; A7878-V01 ; A7977-V01 ; B0030-V02
; B0109-V02 ; B0299-V02 ; B0304-V02 ; B0307-V02 ; B0310-V02 ; B0311-V02 ; B0312-V02
; B0313-V02 ; B0314-V02 ; T0476-V0-2 ; T0752-V01 ; T0985-V02 ; T0988 ; T1145-V01
; T1330-V01 ; T1344-V02 ; T1449-V01 ; T1519 ; T1563-V01 T1838-V01 ; T1840
; T1991-V02 ; T2078-V01 ; T2291-V02 ; T2398-V01 ; T2433-VO2 ; T2446-V02 ; T2525-V01
; T2937 ; T2953 ; T2964-V01 ; T2969-V01 ; T4176-V02 ; t4358-v01 ; T4370-V01
; T4377-V01 ; T4384 ; T4465-V02 ; T4558-V02 ; T4582-V02 ; T4799-V01 ; T5230-V02
; T5388-V02 ; T5390 ; T5439-V01 ; T5449-V01 ; T5561-V02 ; T6012-V01 ; T6042-V02
; T6237-V02 ; T6443-V01 ; T6481-V02 ; T6841-V01 ; T6912 ; T6931-V02 ; T7079-V02
; T730--V02 ; T7930-V01 ; T8111-V01 ; T8288-V01 ; T8458-v01 ; T8673-V01 ; T8684-V01
; T8717-V02 ; T8739-V02 ; T8771-V01 ; T8779-V01 ; T8889-V02 ; T9232-V01 ; T9292-V02
; T9295-V02 ; T9314-V01 ; T9570-V02 ; T9786-V01.
RECALLING FIRM/MANUFACTURER
Power Surgical Solutions, Fort Worth, TX.
REASON
Softer hose increases the propensity for outer exhaust hose to kink or become
occluded as a result of clamping.
VOLUME OF PRODUCT IN COMMERCE
1,432 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
CODE
All systems using software version 3.09.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN.
REASON
Test results may be adversely affected by software shutting down the cooling
blocks in systems with software versions 3.09.
VOLUME OF PRODUCT IN COMMERCE
65.
DISTRIBUTION
Nationwide.
PRODUCT CryoValve, Pulmonary Valve and Conduit.
CODE
Dibir # 75387, Serial #8235992, Model #PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON
The tissue donation was deferred due to possible Hepaititis C suspected by the
MD.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MI.
PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R;
CODE
Serial numbers 200101 to 202190.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., Mc Graw Park, IL.
REASON
The instrument power cord may become disconnected from the instrument and pose
a fire or electrical shock hazard.
VOLUME OF PRODUCT IN COMMERCE
3,004 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange
Device, 1.2 m (48inch); a sterile set consisting of a bag connector (spike connector)
on-off clamp assembly, tubing and double scaling male Luer lock connector; product
code R5C4325.
CODE
Lot H03L12057, expiration date 12/31/08.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., Mc Graw Park, IL.
REASON
Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
VOLUME OF PRODUCT IN COMMERCE
1,152 sets.
DISTRIBUTION
Internationally.
PRODUCT
a) NAMIC Custom Angiographic Kit, Left Heart Kit-
Model #H749651947220. Catalog # 65194722.
b) NAMIC Custom Angiographic Kit, Left Heart Kit.
Model #H7496019054110. Catalog # 601905411.
CODE
a) Lot #990024;
b) Lot #988046.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, Glens Falls, NY.
REASON
The kits contains defective Magellan Monoject Safety Needles. The needle shaft
may separate from the hub.
VOLUME OF PRODUCT IN COMMERCE
154 kits.
DISTRIBUTION
IL and NV.
PRODUCT
a) Genesis Uni Articular Inserts.
b) Tibial Base Plates.
CODE
a) Lot numbers: 71248108, 71248109, 71248110,
71248111, 71248112, 71248208, 71248209,
71248210, 71248211, 71248212, 71248308,
71248309, 71248310, 71248311, 71248312,
71248228, 71248229, 71248230, 71248231,
71248232, 71248235, 71248328, 71248329,
71248330, 71248331, 71248332, 71248335,
71248338, 71248339, 71248340, 71248341,
71248342, 71248345 Sold internationally:
71975865, 71975866, 71975867, 71975870,
71975871, 71975872, 71975873.
b) Tibial Base Plates 726100, 726101, 727100,
727101, 726202, 726203, 727202, 727203,
726304, 726305, 727304, 727305.
RECALLING FIRM/MANUFACTURER
Smith & Nephew Inc., Memphis, TN.
REASON
The firm received confirmed reports of Genesis Uni Articular Inserts not locking
into tibial base plates intraoperatively.
VOLUME OF PRODUCT IN COMMERCE
11,339 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials
processing machine.
CODE
All serial numbers are affected by this recall action. Serial numbers range
from 1003 to 1092.
RECALLING FIRM/MANUFACTURER
Coherent, Inc., Santa Clara, CA.
REASON
Software problem that may cause unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE
75 units.
DISTRIBUTION
NC, Canada, Germany, and Japan.
PRODUCT
Intinion 1.5 T MRI Scanner.
CODE
Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH.
REASON
There is a potential for the patient to be exposed to cryogenic fluids (liquid
air) dripping from the vent during a quench due to the location of the vent.
VOLUME OF PRODUCT IN COMMERCE
172 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Straumann Dental Implant System, SP Profile Drill, Short, 04-2 mm, RN, L25.0
mm, Stainless steel Ref. Number: 044.084.
CODE
Lot Numbers: 1300 and 1301.
RECALLING FIRM/MANUFACTURER
The Straumann Company, Waltham, MA.
REASON
Outside label incorrectly identifies drill as Regular Neck (RN) instead of Wide
Neck (WN).
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
Nationwide.