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

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 — recall Z-1624-2021

U.S. FDA — Device Enforcement · United States · 2021-03-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1624-2021
Date of alert
2021-03-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bioseal Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00630094430096
Reported risk: Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
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.