medical Class II Updated 2020-06-10

American Contract Systems recalls Sterile Custom Packs to be used in surgical procedures.

Recalled Product

Sterile Custom Packs to be used in surgical procedures.


Hazard / Issue

The surgical gowns were manufactured in a facility that is not registered by the FDA.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ACS Tray Numbers: AGPP38I; Lot # 644191, Exp. Date 12/22/2020 (2 kits) and Lot # 713191, Exp. Date 10/14/2020 (12 kits) AGHA64J; Lot # 663191, Exp. Date 12/03/2020 (72 kits) and Lot # 716191, Exp. Date 10/11/2020 (10 kits) WPBU64H; Lot # 670191, Exp. Date 11/26/2020 (16 kits)
View official government recall

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