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

Cardinal Health: Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

Is my product affected?

Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

  • UPC 50192253018989
  • UPC 10192253018981

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

What happened

Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns in X-large size due to potential open packaging seals that could compromise the sterility of the gowns. The affected products were distributed worldwide, including throughout the United States and to Chile, Thailand, Canada, Israel, and various Latin American countries and territories. The recalled gowns are identified by lot numbers 20MEQ001, 21AEQ00, 21BEQ001, 21BEQ002, 21BEQ003, 21CEQ001, 21DEQ001, 21DEQ002, 21EEQ001, 21EEQ002, 21FEQ001, 21FEQ002, 21GEQ001, 21HEQ001, 21HEQ002, 21JEQ001, and 21JEQ002, with UDI codes 50192253018989 (case) and 10192253018981 (each unit).

The source document does not specify a remedy or instructions for what affected consumers should do regarding 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: 146,939 units Lot/code info: Lot Numbers: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (ea)

Source

Official record: FDA (Device enforcement) ↗

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

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