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Showing 66001–66020 of 68218 results

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Medical Device Group Inc.: Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD...

Device separation presenting a choking hazard.

FDAJun 8, 2005Nationwide• Medical Device Group Inc.

Unknown Manufacturer: Keramos Ceramic Femoral Heads. Product consists of cerami...

Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.

FDAJun 8, 2005Nationwide

Boston Scientific Corporation: Vaxcel Plastic Low Profile (non-valved) chest port, with ...

Potential for port housing separation after implantation.

FDAJun 8, 2005Nationwide• Boston Scientific Corporation

Roche Diagnostics Corp.: ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit i...

The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.

FDAJun 7, 2005Nationwide• Roche Diagnostics Corp.

Abbott Laboratories Medisense Products: Xceed Blood Glucose Monitoring System; Recalling Firm/Man...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: FreeStyle Blood Glucose Monitoring System; Recalling Firm...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Depuy Orthopaedics, Inc.: Depuy brand LCS Complete metal backed patella, porocoat, ...

There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.

FDAJun 7, 2005Nationwide• Depuy Orthopaedics, Inc.

Abbott Laboratories Medisense Products: Liberty Glucose Monitoring System; Recalling Firm/Manufac...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: FreeStyle FLASH Blood Glucose Monitoring System; Recallin...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: RiteAid Glucose Monitoring System; Recalling Firm/Manufac...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom: Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label

FDAJun 7, 2005CA, NJ, PA +1 more• Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom

Abbott Laboratories Medisense Products: ReliOn Ultima Glucose Monitoring System; Recalling Firm/M...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: Xtra Classic Glucose Monitoring System; Recalling Firm/Ma...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: Optium Glucose Monitoring System; Recalling Firm/Manufact...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: Boots Glucose Monitoring System Recalling Firm/Manufactur...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

North Coast Medi-Tek Inc: Ultrasound probe cover, sterile. Catalog No. 910811.

Customer observed unsealed packages.

FDAJun 7, 2005OH• North Coast Medi-Tek Inc

Abbott Laboratories Medisense Products: Kroger Glucose Monitoring System; Recalling Firm/Manufact...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: Tracker Blood Glucose Monitoring System; Recalling Firm/...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: Easy Glucose Monitoring System; Recalling Firm/Manufactur...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: SofTrac Glucose Monitoring System; Recalling Firm/Manufac...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

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