Avid Medical, Inc. Recall 87720
Description: FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Avid Medical, Inc. Recall 87720 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1785-2021 |
| Event ID | 87720 |
| Event Description | FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020. |
| Product Type | Devices |
| Distribution | Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN |
| Quantity | 720 kits |
| Recall 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. |
| Device Classification | 20210616 |
| Device Code Info | Part Number: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021) |
| Center Classification Date | 20210604 |
| Recall Initiation Date | 20210409 |
| Recalling Firm | Avid Medical, Inc. |
| Initial Notification | |
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