Sterile Custom Packs to be used in surgical procedures.

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

Code information: ACS Tray Numbers: AGTA481; Lot # 998201, Exp. Date 01/02/2021 (60 kits) WXEN11G; Lot # 994201, Exp. Date 01/06/2021 (32 kits) VSMT20G; Lot # 677191, Exp. Date 11/19/2020 (12 kits) AGHN20J; Lot # 636191, Exp. Date 12/30/2020 (4 kits); Lot # 675191, Exp. Date 11/21/2020 (12 kits) and Lot # 741191, Exp. Date 09/16/2020 (36 kits) AGEN11H; Lot # 657191, Exp. Date 12/09/2020 (66 kits) VSEN11F; Lot # 664191, Exp. Date 12/02/2020 (8 kits)

Distribution pattern: US Nationwide distribution including in the state of Pennsylvania.