FDA-Device2021-05-26Class II
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Bioseal Corporation
Hazard
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.
Sold states
US: IL and MO OUS: None
Affected count
580 units
Manufactured in
167 W Orangethorpe Ave, N/A, Placentia, CA, United States
Products
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1624-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief