Stents, Drains And Dilators For The Biliary Ducts

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common b

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common b

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

CRE Pro Wireguided 6-8mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 8-10mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 10-12mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 15-18mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 18-20mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Extractor Pro RX Retrieval Balloon Catheter;

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.