American Contract Systems: Medical Device Recall in 2020 - (Recall #: Z-2173-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Sterile Custom Packs to be used in surgical procedures.

Product Classification:

Class II

Date Initiated: April 13, 2020

Date Posted: June 10, 2020

Recall Number: Z-2173-2020

Event ID: 85502

Reason for Recall:

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

Status: Terminated

Product Quantity: 2868 total kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated