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: WXCT12E; Lot # 998201, Exp. Date 001/02/2021 (70 kits) PTHS10C; Lot # 664191, Exp. Date 12/02/2020 (2 kits) AVHA64H; Lot # 663191, Exp. Date 12/06/2020 (30 kits) WXPO16G; Lot # 639191, Exp. Date 12/27/2020 (26 kits) and Lot # 689191, Exp. Date 11/07/2020 (6 kits) VSSA12G; Lot # 646191, Exp. Date 12/20/2020 (12 kits) AGBA20H: Lot 3 970191, Exp. Date 01/30/20 (2 kits) WXSA12H; Lot # 653191, Exp. Date 12/13/2020 (40 kits) WXKA26H; Lot # 981201, Exp. Date 01/19/2021 (18 kits) and Lot # 639191, Exp. Date 12/27/2020 (32 kits) WXHA64H; Lot # 682191, Exp. Date 11/14/2020 (18 kits); Lot # 636191, Exp. Date 12/30/2020 (121 kits) and Lot # 684191, Exp. Date 11/12/2020 (6 kits) AGKA26H; Lot # 992201, Exp. Date 01/08/2021 (64 kits)

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