Device product
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Z-0374-2022
Product summary
- Firm
- Cardinal Health
- Event
- Event 89015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29,893 units
- Official record key
device-enforcement:Z-0374-2022
Official wording
Reason: Potential for open packaging seals compromising the sterility of the surgical gowns
Code information: Lot Numbers: 21CKQ001 21CKQ002 21HKQ001. UDI: 50192253005941 (cs) 10192253005943 (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