Device product
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Z-0373-2022
Product summary
- Firm
- Cardinal Health
- Event
- Event 89015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 146,939 units
- Official record key
device-enforcement:Z-0373-2022
Official wording
Reason: Potential for open packaging seals compromising the sterility of the surgical gowns
Code information: Lot Numbers: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (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