FDA recall Z-1624-2021

Product

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

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-1624-2021