Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1785-2021 — FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

U.S. FDA — Device Enforcement · United States · 2021-04-09 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1785-2021
Date of alert
2021-04-09
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Avid Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20809160223489
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.