American Contract Systems: Medical Device Recall in 2020 - (Recall #: Z-2175-2020)

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-2175-2020

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: 2,868 total kits

Code Information:

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)

Distribution Pattern:

US Nationwide distribution including in the state of Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated