FDA recall Z-1417-2020

Deroyal Industries, Inc. Lafollette · Class II · device

Product

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08

Reason for recall

Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Distribution

US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

Key facts

Status
Terminated
Initiation date
2020-02-04
Report date
2020-03-11
Termination date
2021-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Follette, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1417-2020