Recall Z-0069-2018 ยท LRO General Surgery Tray
Windstone Medical Packaging, Inc.
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
| Date | Oct 24, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 60 kits |
| Distribution | US Distribution to the state of : SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.