Wire, Guide, Catheter

Boston Scientific Enhance Transcarotid/Peripheral Access Kit

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Splashwire Hydrophilic Guide Wire:

Due to unsealed portions of pouches.

Description/REF:

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Medline Namic Guidewires:

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

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

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G

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

COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50

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

GALT Guidewire

Due to a potential open seal in the sterile barrier packaging.

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Devices from the affected device lots have labels that state the incorrect expiration dates.

Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW;

Affected device lots have labels that state the incorrect expiration dates.