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Abbott Laboratories MPG: ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each...

There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.

FDADec 21, 2005Nationwide• Abbott Laboratories MPG

Haemonetics Corporation: Haemonetics Cell Saver 5 Autogolous Blood Recovery System...

Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard

FDADec 21, 2005Nationwide• Haemonetics Corporation

Baxter Healthcare Renal Div: Baxter BM25 System ultrafiltration hemodialysis machine; ...

Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.

FDADec 21, 2005Nationwide• Baxter Healthcare Renal Div

Baxter Healthcare Corp. Rt.: Baxter PCA II Syringe Infusion Pump, product codes 2L3104...

Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.

FDADec 21, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: AP II Pain Management System infusion pump, product codes...

Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.

FDADec 21, 2005Nationwide• Baxter Healthcare Corp. Rt.

AGFA Corp.: Agfa Cronex 10T Radiographic film

Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.

FDADec 21, 2005AZ, CA, CO +8 more• AGFA Corp.

Praxair Distribution Inc.: Praxair Grab ''n Go Vantage unit, model PRX-9495.

The units may experience a delay in oxygen flow upon initial actuation.

FDADec 21, 2005CA, IL, IN +5 more• Praxair Distribution Inc.

Stryker Howmedica Osteonics Corp.: 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Labe...

The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

FDADec 20, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Bard Access Systems, Inc: Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access...

Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

FDADec 20, 2005Nationwide• Bard Access Systems, Inc

Bard Access Systems, Inc: Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC.

Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

FDADec 20, 2005Nationwide• Bard Access Systems, Inc

Linvatec Corp.: ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 50...

The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.

FDADec 20, 2005Nationwide• Linvatec Corp.

Boston Scientific Corp: Boston Scientific brand Zero Tip Nitinol Stone Retrieval ...

The basket wire assembly may detach from the drive wire while in the patient.

FDADec 20, 2005Nationwide• Boston Scientific Corp

Fisher & Paykel Healthcare Inc: Fisher & Paykel Healthcare Adult Respiratory Ventilator C...

Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.

FDADec 20, 2005Nationwide• Fisher & Paykel Healthcare Inc

Stentor Inc: ''iSite'' PowerScribe/iSite Integration, Picture Archivin...

When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens

FDADec 20, 2005Nationwide• Stentor Inc

Exactech, Inc.: Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T...

An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.

FDADec 19, 2005AL, LA• Exactech, Inc.

Abbott Laboratories: CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology ...

T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

FDADec 16, 2005Nationwide• Abbott Laboratories

Chembio Diagnostic System Inc: Sickle-STAT Test Kit, Catalog # SC901, a qualitative test...

Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.

FDADec 16, 2005Nationwide• Chembio Diagnostic System Inc

Smiths Medical ASD, Inc.: Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hy...

Sterility is compromised by incomplete package seal.

FDADec 16, 2005Nationwide• Smiths Medical ASD, Inc.

Instrumentation Laboratory Co.: GEM PREMIER 3000

Software error may report higher results for glucose and lactate

FDADec 16, 2005Nationwide• Instrumentation Laboratory Co.

Smiths Medical ASD, Inc.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheo...

Sterility is compromised by incomplete package seal.

FDADec 16, 2005Nationwide• Smiths Medical ASD, Inc.

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