—#159349

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot # 109138

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern: US Distribution to the state of : SC

Timeline

Recall initiated: 2017-10-24
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.