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

Cardinal Health: RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578

Is my product affected?

RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578

  • UPC 50192253006184
  • UPC 10192253006186

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

What happened

Cardinal Health is recalling 9,990 units of RoyalSilk Non-Reinforced Surgical Gowns in XX-large size due to potential for open packaging seals that could compromise the sterility of the gowns. The affected product was distributed worldwide, including across the United States and to Chile, Thailand, Canada, Israel, and various Latin American countries. The recall involves ten specific lot numbers ranging from 20MLQ001 through 21HLQ001.

The record does not specify a remedy or action that affected consumers should take.

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: 9,990 units Lot/code info: Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)

Source

Official record: FDA (Device enforcement) ↗

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

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