FDA Device recall Z-1785-2021
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020
- FDA Device
- Class I
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class I recall of FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020 by Avid Medical, citing 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 ap….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1785-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-04-09 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
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.
Identifiers
| code_info | Part Number: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1785-2021%22
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