AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
This recall has been terminated (originally issued October 24, 2017).
- Recall Initiated
- October 24, 2017
- Terminated
- July 2, 2018
- Recall Number
- Z-0069-2018
- Quantity
- 60 kits
- Firm Location
- Billings, MT
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution to the state of : SC
Lot / Code Info
Lot # 109138
Root Cause
Nonconforming Material/Component
Action Taken
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.