The Recall Desk
HighFDA (Devices)·Z-0828-2024·Announced 2024-02-07

Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects

American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.

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 affecting surgical kits with potential loss of functionality and reduced drug efficacy. No hospitalizations or injuries have been reported. This meets the rubric criterion for Score 3 (High): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

American Contract Systems, Inc. is recalling 1,020 custom obstetrical and gynecological surgical kits distributed nationwide. The kits are used in obstetrical and gynecological procedures and come in multiple models identified by kit number (including AGLP52L, HGOB98G, HHDV17, MMGR44D, MMJL16E, SMGY46, THLH71C, UIHY16AA, and WELP67C variants).

During an internal investigation, the manufacturer identified several components that were "piggybacked" (added) to the kits and subjected to the company's sterilization process. The issue: there is no documentation confirming whether these components were assessed to determine if they were suitable for exposure to elevated temperatures and extended sterilization.

Without this assessment, the affected components may experience loss or lack of functionality, loss of drug efficacy (where applicable), or may contain higher-than-specified levels of ethylene oxide (EO) sterilization residue. These defects could affect the safety and performance of the kits during procedures.

Affected lot numbers are identified by kit number and expiration date. Users should identify the kit model number and lot number, discontinue use of affected kits, and contact American Contract Systems, Inc. for replacement or proper disposition instructions.

The recalled product

Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
Manufacturer
American Contract Systems, Inc.
Category
Medical Device — Surgical Kits / Obstetrical & Gynecological
Hazard
Affected units
1,020

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) AGLP52L
  • UDI/DI 00191072144119
  • Lot Numbers: 933231
  • exp. 3/8/2024
  • 942231
  • exp. 2/27/2024
  • 947231
  • exp. 2/22/2024
  • 966231
  • exp. 2/3/2024
  • 980231
  • exp. 1/20/2024
  • 681221
  • exp. 11/15/2023
  • 707221
  • exp. 10/20/2023
  • b) HGOB98G
  • UDI/DI none
  • Lot Numbers: 667221
  • exp. 11/29/2023

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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