Z-1418-2020 Class II Terminated
FDA device recall Z-1418-2020 was initiated by Deroyal Industries, Inc. Lafollette on February 4, 2020 and is designated Class II. Reason for recall: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The recall status is terminated (terminated April 1, 2021). Affected quantity: 2100 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- February 4, 2020
- Termination Date
- April 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2100 units
Product Description
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Reason for Recall
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Distribution Pattern
US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
Code Information
Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Kwik Kit 89-6389.06, Lot number: 49624025 exp. 07/01/2023