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: AGLH66F; Lot # 674191, Exp. Date [date] (244 kits) AGAD45I; Lot# 681191, Exp. Date 11/15/2020 (35 kits)
View official government recall

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