Device product
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Z-0377-2022
Product summary
- Firm
- Cardinal Health
- Event
- Event 89015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,990 units
- Official record key
device-enforcement:Z-0377-2022
Official wording
Reason: Potential for open packaging seals compromising the sterility of the surgical gowns
Code information: Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (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