The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2173-2020·Announced 2020-06-10

FDA Recalls Sterile Surgical Packs from Unregistered Facility

American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered with the FDA.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue (unregistered facility) rather than a confirmed biological or chemical contamination, fitting the criteria for a moderate severity voluntary precautionary recall.

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 is American Contract Systems. The total quantity involved in this recall is 2,868 kits.

The reason for the recall is that the surgical gowns included 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. Specific lot numbers and expiration dates are listed in the agency's official recall notice.

Healthcare facilities and consumers who have these specific sterile custom packs should stop using them immediately. They should contact American Contract Systems or their supplier for instructions on how to return or dispose of the products. The FDA advises checking the lot numbers and expiration dates against the official recall list to determine if the products in their possession are affected.

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 (16)

  • ACS Tray Numbers: AGTA481
  • Lot # 998201
  • Exp. Date 01/02/2021 (60 kits) WXEN11G
  • Lot # 994201
  • Exp. Date 01/06/2021 (32 kits) VSMT20G
  • Lot # 677191
  • Exp. Date 11/19/2020 (12 kits) AGHN20J
  • Lot # 636191
  • Exp. Date 12/30/2020 (4 kits)
  • Lot # 675191
  • Exp. Date 11/21/2020 (12 kits) and Lot # 741191
  • Exp. Date 09/16/2020 (36 kits) AGEN11H
  • Lot # 657191
  • Exp. Date 12/09/2020 (66 kits) VSEN11F
  • Lot # 664191
  • Exp. Date 12/02/2020 (8 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 →

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