Device product
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Z-0378-2022
Product summary
- Firm
- Cardinal Health
- Event
- Event 89015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,950 units
- Official record key
device-enforcement:Z-0378-2022
Official wording
Reason: Potential for open packaging seals compromising the sterility of the surgical gowns
Code information: Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (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