American Contract Systems: Medical Device Recall in 2020 - (Recall #: Z-2178-2020)

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-2178-2020

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: 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)

Distribution Pattern:

US Nationwide distribution including in the state of Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated