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

ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04 — recall Z-1784-2021

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-1784-2021
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)
20809160261016
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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.