The Recall Desk
HighFDA (Devices)·Z-0827-2024·Announced 2024-02-07

Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures

American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.

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: FDA Class II medical device recall with no reported injuries or illnesses. The hazards are theoretical—potential loss of functionality, efficacy, or excess sterilization residuals—rather than actualized patient harm. This qualifies as a risk-of-harm product (surgical instruments in neurosurgery) where injury has not yet been reported.

Plain-English summary

American Contract Systems, Inc. has recalled 2,717 custom procedural convenience kits and trays for general hospital use, including neurosurgical procedures. The recalled products were distributed nationwide and include multiple kit types such as IR Neuro Pack, Adult Craniotomy Pack, Laminectomy Pack, and others used for craniotomy, laminectomy, and neuro interventional procedures.

During an internal investigation, the company identified that several components were "piggybacked" to the kits and subjected to ACS's sterilization process without supporting documentation. There was no documented assessment of whether these piggybacked components were suitable for exposure to elevated temperatures and the sterilization process.

As a result, the piggybacked components may have a loss or lack of functionality, loss of drug efficacy (if applicable), or higher-than-specified ethylene oxide residuals. Such conditions could affect the safety and effectiveness of these surgical procedure kits.

Healthcare facilities currently using these kits should stop use and contact American Contract Systems for further guidance and return instructions. Affected lot numbers, expiration dates, and specific product identification details are available from the FDA.

The recalled product

Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
Manufacturer
American Contract Systems, Inc.
Category
Medical Device — Neurosurgical Procedure Kits
Hazard
Affected units
2,717

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)

  • a) AGNE20J
  • UDI/DI 00191072183187
  • Lot Numbers: 934231
  • exp. 10/30/2023
  • 900231
  • exp. 4/10/2024
  • 990231
  • exp. 1/10/2024
  • 687221
  • exp. 11/9/2023
  • 720221
  • exp. 10/7/2023
  • 757221
  • exp. 8/31/2023
  • 870221
  • exp. 5/10/2023
  • 702221
  • exp. 10/25/2023
  • 795221
  • exp. 7/24/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by American Contract Systems, Inc. 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 18 products in this recall →

Related recalls

Same manufacturer · American Contract Systems, Inc.

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Same hazard · loss of functionality

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