American Contract Systems: Medical Device Recall in 2020 - (Recall #: Z-2176-2020)

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-2176-2020

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: 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)

Distribution Pattern:

US Nationwide distribution including in the state of Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated