Z-1079-2021 Class II Terminated
FDA device recall Z-1079-2021 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
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
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
Lot: 911609X