SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Check against the official notice below — it lists the full affected range.
Cardinal Health is recalling 224,312 units of SmartGown Breathable Surgical Gowns with raglan sleeves in X-large, X-long, A-line sizes due to the potential for open packaging seals that could compromise the sterility of the gowns. The affected gowns 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 20MFQ001 through 21JFQ001.
The source document does not specify a remedy or what action affected consumers should take in response to 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: 224,312 units Lot/code info: Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.