The Recall Desk
HighFDA (Devices)·Z-0830-2024·Announced 2024-02-07

Surgical kits for childbirth recalled for sterilization and functionality risks

American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.

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: This is a Class II medical device recall affecting surgical kits used in critical obstetrical procedures. The sterilization integrity issues and potential loss of functionality and efficacy constitute risk of harm, though no injuries or illnesses have been reported.

Plain-English summary

American Contract Systems, Inc. is recalling 1,818 custom procedural kits and trays for obstetrical and gynecological use, distributed nationwide. The recalled products include multiple C-section pack variants with kit numbers FDCS01AA, FDCS01AB, HGCS68J, HICS50H, LLCI66, RBCS12R, THCS49B, and UICS50AG.

The company identified during an internal investigation that several components were added to the sterilization trays without proper documentation or assessment. These components were not evaluated to determine if they could safely withstand the elevated temperatures and extended sterilization exposure that the kits undergo.

Due to this lack of assessment, the components may have experienced loss or lack of functionality, loss of drug efficacy where applicable, and may have accumulated higher than specified ethylene oxide (EO) residuals from the sterilization process. These conditions could compromise the safety and effectiveness of the surgical kits when used in medical procedures.

The recalled product

Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
Manufacturer
American Contract Systems, Inc.
Category
Medical Device — Surgical Kits
Hazard
  • eo-residuals
  • device-malfunction
  • efficacy-loss

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) FDCS01AA
  • UDI/DI 00191072179890
  • Lot Numbers: 708221
  • exp. 10/23/2023
  • 646221
  • exp. 12/20/2023
  • b) FDCS01AB
  • UDI/DI 00191072185273
  • Lot Numbers: 886231
  • exp. 4/24/2024
  • c) HGCS68J
  • UDI/DI none
  • Lot Numbers: 702221
  • exp. 10/22/2023
  • 654221
  • exp. 12/12/2023
  • 960231
  • exp. 2/9/2024
  • 903231
  • exp. 4/7/2024

Distribution

Distributed nationwide across the United States.

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