Recall Z-1785-2021 ยท LRO General Surgery Tray
Avid Medical, Inc.
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
| Date | Jun 4, 2021 (initiated Apr 9, 2021) |
| Status | Terminated |
| Reason | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits. |
| Root cause | Environmental control |
| Action | A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to consignees on 04/09/2021 via a email. End-users were notified on 4/13/21. The letter instructs the consignee to immediately examine all inventory locations and discontinue use of all Halyard or AVID branded Procedure Trays subject to the field action. Discard all affected Procedure Trays found in inventory. In addition, if the consignees has further distributed this product, the notice instructs the consignee to please identify their customers and notify them at once of this product correction and requirements. |
| Quantity | 720 kits |
| Distribution | Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.