Z-1082-2021 Class II Terminated
FDA device recall Z-1082-2021 was initiated by Cardinal Health 200, LLC on January 7, 2021 and is designated Class II. 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. The recall status is terminated (terminated February 14, 2024). Affected quantity: 137,346 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- January 7, 2021
- Termination Date
- February 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 137,346 kits
Product Description
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
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 Pattern
Global Distribution. US Nationwide.
Code Information
Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X