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FDA (Device enforcement)Recalled 2021-11-02class ii

Cardinal Health: RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998

Is my product affected?

RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998

  • UPC 50192253006191
  • UPC 10192253006193

Check against the official notice below — it lists the full affected range.

What happened

Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns in XXX-large, X-long size (SKU: 95998) due to potential for open packaging seals that could compromise the sterility of the gowns. Approximately 8,950 units were distributed worldwide, including throughout the United States and in Chile, Thailand, Canada, Israel, and various Latin American countries. The affected products are identified by lot numbers 20MMQ007, 21BMQ007, 21CMQ008, 21DMQ001, 21EMQ003, and 21FMQ007, with UDI numbers 50192253006191 (case) and 10192253006193 (each).

The source does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for open packaging seals compromising the sterility of the surgical gowns

Details from the source

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: 8,950 units Lot/code info: Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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