American Contract Systems: Medical Device Recall in 2020 - (Recall #: Z-2171-2020)

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-2171-2020

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

Distribution Pattern:

US Nationwide distribution including in the state of Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated