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Showing 3741–3760 of 8389 results

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BiMobile Dual Mobility System (Waldemar Link) – Mislabeling Risk (2024)

Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

FDAJan 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Homecare Series Bed (Invacare) – Weld Defect Potential (2024)

Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components

FDAJan 22, 2024Nationwide• Invacare Corporation

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Moderate

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Duet External Drainage System (Medtronic) – Catheter Disconnection Risk (2024)

Potential for catheter disconnection from the patient line stopcock connectors.

FDAJan 22, 2024Nationwide• Medtronic Neurosurgery

VITROS 5600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Epidural Tray (B. Braun) – Connector Compatibility Issue (2024)

Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.

FDAJan 22, 2024Nationwide• B. Braun Medical, Inc.

VITROS XT7600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

GORE VIABIL Biliary Endoprosthesis (Gore) – Mislabeling Risk (2024)

Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.

FDAJan 19, 2024Nationwide• W.L. Gore & Associates, Inc.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Combo Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

ConvaTec Natura Stomahesive System (ConvaTec) – Coupling Ring Mismatch (2024)

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

FDAJan 17, 2024AK, CA, FL +9 more• ConvaTec, Inc

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