The Recall Desk
HighFDA (Devices)·Z-2167-2020·Announced 2020-06-10

FDA Recalls Sterile Surgical Packs from 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. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk-of-harm product where injury has not yet been reported.

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 recalling firm, American Contract Systems, is withdrawing 2,868 total kits from the market. The specific 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 include specific tray numbers and lot numbers: AGCY21I (Lot # 664191, Exp. date 12/02/20, 72 kits) and WXCY21F (Lot # 661191, Exp. date 12/05/20, 32 kits). These products were distributed nationwide in the United States, including in the state of Pennsylvania.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected sterile custom packs immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Sterile Custom Packs to be used in surgical procedures.
Manufacturer
American Contract Systems
Category
Medical Device — Surgical Supplies
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 (5)

  • ACS Tray Numbers: AGCY21I
  • Lot # 664191
  • Exp. date 12/02/20 (72 kits) WXCY21F
  • Lot # 661191
  • Exp. date 12/05/20 (32 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

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Same hazard · unregistered facility

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