FDAFDA · Food and drugs·Recall number Z-0376-2022
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Published December 22, 2021 · Recall initiated: November 2, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for open packaging seals compromising the sterility of the surgical gowns
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health
- Distributor
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- Lot
- Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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