The Recall Desk
ModerateFDA (Devices)·Z-2175-2020·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 by the FDA.

What this means for you

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 specific contamination hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

American Contract Systems is recalling 2,868 sterile custom packs intended for use in surgical procedures. The recall was initiated because 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 lots and tray numbers are identified in the agency's recall notice, including AGMV151, WXMV15H, AGLA66H, AGLP521, AGVA31H, and AGIF04F.

Healthcare facilities and consumers should stop using these products and contact American Contract Systems for further instructions or a refund.

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 (13)

  • ACS Tray Numbers: AGMV151
  • Lot # 993201
  • Exp. Date 01/07/2021 (12 kits) and Lot # 676191
  • Exp. Date 11/20/2020 (18 kits) WXMV15H
  • Lot # 663191
  • Exp. Date 12/03/2020 (32 kits) AGLA66H
  • Lot # 675191
  • Exp. Date 11/21/2020 (4 kits) AGLP521
  • Lot # 648191
  • Exp. Date 12/18/2020 (6 kits) AGVA31H
  • Exp. Date 11/21/2020 (6 kits) AGIF04F
  • Lot # 683191
  • Exp. Date 11/13/2020 (50 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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