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

Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 — recall Z-1554-2021

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-1554-2021
Date of alert
2021-04-09
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medical Action Industries, Inc. 306
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed US nationwide to OH, OR, FL and CA.
Barcode (EAN/GTIN)
20809160247775
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.
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.

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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.