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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: May 29, 2020
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Affected Products

Product: Sterile Custom Packs to be used in surgical procedures.

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)

Lot Numbers:
676191
676191
688191
635191
711191
991201
843191
643191
716191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: AGCY21I; Lot # 664191, Exp. date 12/02/20 (72 kits) WXCY21F; Lot # 661191, Exp. date 12/05/20 (32 kits)

Lot Numbers:
664191
661191
Product: Custom Packs to be used in surgical procedures.

WPGA21L; Lot # 998201, Exp. Date 01/02/2021 (24 kits) and Lot # 6781914, Exp date 11/18/2020 (4 kits) AGGL48H; Lot# 643191, Exp. Date 12/23/2020 (80 kits) AGGM59N: Lot # 761191, Exp. Date 08/27/2020 (5 kits)

Lot Numbers:
998201
6781914
643191
761191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: FBPL271; Lot # 656191, Exp. Date 12/10/2020 (32 kits)

Lot Numbers:
656191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: WPPP52E; Lot # 723191, Exp. Date 10/04/2020 (24 kits) AGMM60M; Lot # 656191, Exp. Date 12/10/2020 (20 kits) VSMI14G; Lot # 643191, Exp. Date 12/23/2020 (60) and Lot #71891, Exp. Date 10/09/2020 (6 kits) WXOLO48H; Lot # 654191, Exp. Date 12/12/2020 (6 kits) AGKD5OJ; Lot # 997201, Exp. Date 01/03/2021 (26 kits) AGME44J; Lot # 997201, Exp. Date 01/03/2021 (24 kits) AGMA31K; Lot # 642191, Exp. Date 12/24/2020 (96 kits) AGMI141; Lot # 671191, Exp. Date 11/25/2020 (36 kits) and Lot # 789191, Exp. Date 07/30/2020 (14 kits) AVMA31I; Lot # 675191, Exp. Date 11/21/2020 (2 kits) AVMI14H; Lot # 639191, Exp. Date 12/27/2020 (70 kits) WXMI14H; Lot # 650191, Exp. Date 12/16/2020 (160 kits) AGLO48H; Lot # 670191, Exp. Date 11/26/2020 (30 kits) SVMA21I; Lot # 654191, Exp. Date 12/12/2020 (30 kits)

Lot Numbers:
723191
656191
643191
71891
654191
997201
997201
642191
671191
789191
675191
639191
650191
670191
654191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: AGLH66F; Lot # 674191, Exp. Date [date] (244 kits) AGAD45I; Lot# 681191, Exp. Date 11/15/2020 (35 kits)

Lot Numbers:
674191
681191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: AGD1401; Lot # 647191, Exp. Date 06/31/2020 (72 kits) and Lot # 685191 Exp. Date 03/31/2020 (6 kits) WPP147H; Lot # 684191, Exp. Date 11/12/2020 (20 kits) and Lot # 723191 Exp. Date 10/04/2020 (4 kits) SVOH38N; Lot # 654191, Exp. Date 12/12/2020 (32 kits)

Lot Numbers:
647191
685191
684191
723191
654191
Product: Sterile Custom Packs to be used in surgical procedures.

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)

Lot Numbers:
998201
994201
677191
636191
675191
741191
657191
664191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: FBCS38I; Lot # 692191, Exp. Date 11/04/2020 (4 kits) and Lot # 648191,Exp. Date 12/18/2020 (40 kits)

Lot Numbers:
692191
648191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: AGMV151; Lot # 993201, Exp. Date 01/07/2021 (12 kits) and Lot # 676191,Exp. Date 11/20/2020 (18 kits) WXMV15H; Lot # 663191, Exp. Date 12/03/2020 (32 kits) AGLA66H; Lot # 675191, Exp. Date 11/21/2020 (4 kits) AGLP521; Lot # 648191, Exp. Date 12/18/2020 (6 kits) AGVA31H; Lot # 675191, Exp. Date 11/21/2020 (6 kits) AGIF04F; Lot # 683191, Exp. Date 11/13/2020 (50 kits)

Lot Numbers:
993201
676191
663191
675191
648191
675191
683191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: AGSBOO6K; Lot # 660191, Exp. Date 12/06/2020 (19 kits) AGDB14J; Lot # 737191, Exp. Date 09/20/2020 (2 kits) AHLA17J; Lot # 653191, Exp. Date 12/13/2020 (12 kits) SVNE16K; Lot # 691191, Exp. Date 11/05/2020 (20 kits) WPLA17I; Lot # 685191, Exp. Date 11/11/2020 (2 kits)

Lot Numbers:
660191
737191
653191
691191
685191
Product: Sterile Custom Packs to be used in surgical procedures.

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)

Lot Numbers:
998201
664191
663191
639191
689191
646191
653191
981201
639191
682191
636191
684191
992201
Product: Sterile Custom Packs to be used in surgical procedures.

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)

Lot Numbers:
644191
713191
663191
716191
670191
Product: Sterile Custom Packs to be used in surgical procedures.

ACS Tray Numbers: AVLC19G; Lot # 642191, Exp. Date 12/24/2020 (64 kits)

Lot Numbers:
642191

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85502
Status: Resolved
Manufacturer: American Contract Systems
Manufactured In: United States
Units Affected: 14 products (2,868 surgical kits total; 2,868 total kits; 2, 868 total kits; 2, 868 total kits; 2,868 kits; 2868 total kits; 2868 kits total; 2868 total kits; 2868 total kits; 2,868 total kits; 2868 total kits; 2,8,68 total kits; 2, 868 total kits; 2,868 total kits)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.