American Contract Systems recalls obstetrical and gynecological procedural kits due to potential loss of functionality or drug efficacy from improper sterilization processes.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
American Contract Systems is recalling specific obstetrical and gynecological procedural kits because some components were not properly tested for heat exposure during sterilization. This could lead to kits not working correctly or reduced effectiveness of medications if used.
During sterilization, some components were added without proper testing for heat exposure. This could cause the components to lose functionality or reduce medication effectiveness, but does not pose a direct safety risk like injury or fire.
Healthcare providers using these kits for obstetrical and gynecological procedures are likely affected. The risk is low as the issue relates to potential functionality or drug efficacy rather than immediate safety hazards.
Check for kit labels with model numbers: AGLP52L, HGOB98G, HHDV17, MMGR44D, MMJL16E, SMGY46, THLH71C, UIHY16AA, WELP67C, or WELP67C-01/02. These kits were sold with specific expiration dates listed in the recall notice.
Look for model numbers on the kit labels: AGLP52L, HGOB98G, HHDV17, MMGR44D, MMJL16E, SMGY46, THLH71C, UIHY16AA, WELP67C, or WELP67C-01/02.
American Contract Systems identified that some components were added without proper testing for heat exposure during sterilization, which could lead to loss of functionality or reduced medication effectiveness.
Check the kit label for the model number listed in the recall. If it matches, contact American Contract Systems for further instructions.
The recall indicates potential loss of functionality or reduced medication effectiveness, but not immediate safety risks like injury or fire.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0828-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0828-2024 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
