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: SVOH98F; Lot # 676191, Exp. date 11/20/20 (3 kits) AHMV261; Lot # 676191, Exp. date 11/20/20 (10 kits) AGMV26L: Lot # 688191, Exp. date 11/08/2020 (36 kits) FBTO60G: Lot # 635191, Exp. date 12/31/2020 (25 kits) FBTO60G: Lot # 711191, Exp. date 10/16/2020 (3 kits) AGEP48G: Lot # 991201, Exp. date 01/09/2021 (72 kits) AGBR90D: Lot # 843191, Exp. date 06/06/2020 (48 kits) AGTP52J: Lot # 643191, Exp. date 12/23/2020 (42 kits) AGTP52J: Lot # 716191, Exp. date 10/11/2020 (8 kits)

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