Z-1415-2020 Class II Terminated
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: ASC Laparoscopy Pack 89-6138.13
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; f. ASC Laparoscopy Pack 89-6138.13, Lot number: 49505093 exp.10/01/2023;