FISTULA — Class I medical device recall Z-1786-2021
Terminated recall by Avid Medical, Inc., reported 2021-06-16, distributed nationwide. Medical convenience kits are being recalled due to a potential breach in the package integrity of a component,
| Recall number | Z-1786-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avid Medical, Inc., Toano, VA, United States |
| Recall initiated | 2021-04-09 |
| Classified | 2021-06-04 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2022-07-18 |
| Distributed | Nationwide (US) |
| Quantity | 160 kits |
| Reason classes | packaging |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 20809160342500 |
| Lot numbers | 1445301 |
| Model numbers | VAMK024-03 |
| Expiration dates | 2022-04-30 |
Product
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1786-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.