Device product
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Z-0372-2022
Product summary
- Firm
- Cardinal Health
- Event
- Event 89015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,174 units
- Official record key
device-enforcement:Z-0372-2022
Official wording
Reason: Potential for open packaging seals compromising the sterility of the surgical gowns
Code information: Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)
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.
Derived failure modes
-
Labeling or packaging
open packaging