FDA Recall
Terminated
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Recall: Z-0069-2018
·
Initiated October 24, 2017
Recall
- Recall Number
- Z-0069-2018
- Event Number
- 78366
- Firm
- Windstone Medical Packaging, Inc.
- FEI Number
- 1000125955
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 24, 2017
- Terminated
- July 2, 2018
- Address
- 1602 4th Ave N, Billings, MT, 59101-1521
Description
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Reason
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.
Action
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.
Distribution
US Distribution to the state of : SC
Quantity
60 kits