RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Check against the official notice below — it lists the full affected range.
Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns in X-large size due to a potential for open packaging seals that could compromise the sterility of the gowns. The affected products were distributed worldwide, including throughout the United States and in Chile, Thailand, Canada, Israel, and various Latin American countries. The recall involves multiple lot numbers ranging from 20MMQ004 through 21HMQ006.
Consumers can identify affected products by checking the lot number or UDI (Unique Device Identifier) printed on the packaging. The record does not specify what actions affected consumers should take regarding this recall.
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: 270,839 units Lot/code info: Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.