RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Check against the official notice below — it lists the full affected range.
Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns in Large size due to potential for open packaging seals that could compromise the sterility of the gowns. The recall affects 364,481 units that were distributed worldwide, including across the United States and to Chile, Thailand, Canada, Israel, and several Latin American countries. The affected products are identified by specific lot numbers (20MMQ001 through 21HMQ001) and UDI codes 50192253006160 (case) and 10192253006162 (each unit).
The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for open packaging seals compromising the sterility of the surgical gowns
Reason for recall: Potential for open packaging seals compromising the sterility of the surgical gowns Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica. Quantity: 364,481 units Lot/code info: Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.