FDA recall Z-1622-2021

Bioseal Corporation · Class II · device

Product

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

Reason for recall

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.

Distribution

US: IL and MO OUS: None

Key facts

Status: Completed
Initiation date: 2021-03-23
Report date: 2021-05-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Placentia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1622-2021