The Recall Desk
HighFDA (Devices)·Z-2177-2020·Announced 2020-06-10

FDA Recalls Sterile Surgical Packs from Unregistered Facility

American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the use of medical devices from an unregistered facility, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for sterile custom packs intended for use in surgical procedures. The recall is being conducted by American Contract Systems. The agency has classified this recall as Class II.

The reason for the recall is that the surgical gowns contained in these packs were manufactured in a facility that is not registered by the FDA. The affected products were distributed nationwide in the United States, including in the state of Pennsylvania. The recall involves 2,868 total kits across various lot numbers and expiration dates.

Healthcare facilities and consumers who have these sterile custom packs should stop using them immediately. They should contact American Contract Systems for instructions on how to return or dispose of the products.

The recalled product

Product
Sterile Custom Packs to be used in surgical procedures.
Manufacturer
American Contract Systems
Category
Medical Device — Surgical Packs
Hazard
Affected units
2,868

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ACS Tray Numbers: WXCT12E
  • Lot # 998201
  • Exp. Date 001/02/2021 (70 kits) PTHS10C
  • Lot # 664191
  • Exp. Date 12/02/2020 (2 kits) AVHA64H
  • Lot # 663191
  • Exp. Date 12/06/2020 (30 kits) WXPO16G
  • Lot # 639191
  • Exp. Date 12/27/2020 (26 kits) and Lot # 689191
  • Exp. Date 11/07/2020 (6 kits) VSSA12G
  • Lot # 646191
  • Exp. Date 12/20/2020 (12 kits) AGBA20H: Lot 3 970191
  • Exp. Date 01/30/20 (2 kits) WXSA12H
  • Lot # 653191
  • Exp. Date 12/13/2020 (40 kits) WXKA26H
  • Lot # 981201
  • Exp. Date 01/19/2021 (18 kits) and Lot # 639191
  • Exp. Date 12/27/2020 (32 kits) WXHA64H
  • Lot # 682191
  • Exp. Date 11/14/2020 (18 kits)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 14 recalled by American Contract Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · American Contract Systems

See all →

Same hazard · unregistered facility

See all →