Z-0378-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 2, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,950 units
Product Description
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Reason for Recall
Potential for open packaging seals compromising the sterility of the surgical gowns
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.
Code Information
Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)