American Contract Systems recalls obstetrical and gynecological kits with potential sterilization issues affecting functionality and drug efficacy.
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 obstetrical and gynecological procedural kits that may have been improperly sterilized, risking loss of function or reduced drug effectiveness. This could impact medical procedures requiring precise equipment.
The kits were found to have components that were not properly assessed for sterilization exposure. This could lead to components losing functionality or having higher than intended sterilant residues, potentially reducing drug effectiveness.
Healthcare providers using these kits for obstetrical and gynecological procedures are most at risk. Patients using these kits during medical treatments could be affected if the kits malfunction.
Check for kits labeled 'LavH' (kit number BBLV21C) or 'LAP HYST' (kit number BFHY75U). These kits were sold with specific lot numbers and expiration dates listed in the recall notice.
Look for labels indicating 'LavH' (kit number BBLV21C) or 'LAP HYST' (kit number BFHY75U).
The kits may have components that lost functionality or reduced drug effectiveness due to improper sterilization assessment.
Check for labels 'LavH' (kit number BBLV21C) or 'LAP HYST' (kit number BFHY75U) with specific lot numbers and expiration dates listed in the recall notice.
The recall does not require immediate discontinuation; users should check labels and follow the provided steps.
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-0831-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0831-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
