FDA Device

AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

Hazard

Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.

What You Should Do

Remedy

The firm (AMS) initiated the recall by email on October 24, 2017. The firm requested that the consignee identify and quarantine the product. Respond to AMS with a count and AMS will provide labeling (stickers) for the consignee to affix to the exterior of the kit. The sticker identifies the affected component and requests removal and destruction. For further questions, please call (406) 259-6387.

Products

AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Brand
Windstone Medical Packaging, Inc.
UPC
Lot # 109138

Units Affected

60 kits