Device product
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Z-0370-2022
Product summary
- Firm
- Cardinal Health
- Event
- Event 89015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 231,219 units
- Official record key
device-enforcement:Z-0370-2022
Official wording
Reason: Potential for open packaging seals compromising the sterility of the surgical gowns
Code information: Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (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