FDA recall Z-1078-2021

Cardinal Health 200, LLC · Class II · device

Product

Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Distribution

Global Distribution. US Nationwide.

Key facts

Status: Terminated
Initiation date: 2021-01-07
Report date: 2021-02-17
Termination date: 2024-02-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2021