The Recall Desk
HighFDA (Devices)·Z-2170-2020·Announced 2020-06-10

FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

American Contract Systems is recalling 2,868 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 presents a risk of harm to patients 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 Class II recall for 2,868 sterile custom packs intended for use in surgical procedures. The recalling firm, American Contract Systems, identified that the surgical gowns included in these packs were manufactured in a facility that is not registered by the FDA.

The affected products are distributed nationwide in the United States, including in the state of Pennsylvania. Specific lot numbers and expiration dates for the recalled kits are detailed in the agency's official recall notice.

Consumers and healthcare facilities should stop using these products immediately. The FDA advises that the use of medical devices manufactured in unregistered facilities may pose a risk to patient safety due to the lack of regulatory oversight over the manufacturing process.

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: WPPP52E
  • Lot # 723191
  • Exp. Date 10/04/2020 (24 kits) AGMM60M
  • Lot # 656191
  • Exp. Date 12/10/2020 (20 kits) VSMI14G
  • Lot # 643191
  • Exp. Date 12/23/2020 (60) and Lot #71891
  • Exp. Date 10/09/2020 (6 kits) WXOLO48H
  • Lot # 654191
  • Exp. Date 12/12/2020 (6 kits) AGKD5OJ
  • Lot # 997201
  • Exp. Date 01/03/2021 (26 kits) AGME44J
  • Exp. Date 01/03/2021 (24 kits) AGMA31K
  • Lot # 642191
  • Exp. Date 12/24/2020 (96 kits) AGMI141
  • Lot # 671191
  • Exp. Date 11/25/2020 (36 kits) and Lot # 789191
  • Exp. Date 07/30/2020 (14 kits) AVMA31I
  • Lot # 675191
  • Exp. Date 11/21/2020 (2 kits) AVMI14H

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

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Same hazard · unregistered facility

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