Z-0372-2022 Class II Ongoing
FDA device recall Z-0372-2022 was initiated by Cardinal Health on November 2, 2021 and is designated Class II. Reason for recall: Potential for open packaging seals compromising the sterility of the surgical gowns The recall status is ongoing. Affected quantity: 17,174 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 2, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,174 units
Product Description
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Reason for Recall
Potential for open packaging seals compromising the sterility of the surgical gowns
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Code Information
Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)