American Contract Systems recalls obstetrical kits with potential component failure due to improper sterilization. Affected kits include C-Section packs with specific model numbers and expiration dates.
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 surgical kits that may have components that don't work properly or lose drug effectiveness after being sterilized. This could lead to kit failure during medical procedures.
The kits were assembled with components that weren't properly tested for heat and sterilization exposure. This could cause parts to malfunction or lose effectiveness, potentially affecting surgical outcomes.
Healthcare providers using these kits for C-sections and other obstetrical procedures are most at risk. Patients undergoing surgery with these kits could face potential complications.
Check for kit labels with model numbers like FDCS01AA, FDCS01AB, HGCS68J, HICS50H, LLCI66, RBCS12R, THCS49B, or UICS50AG. These kits were sold with specific expiration dates and lot numbers.
Look for model numbers and expiration dates on the kit labels to determine if it's affected.
The affected kits include C-Section packs with model numbers FDCS01AA, FDCS01AB, HGCS68J, HICS50H, LLCI66, RBCS12R, THCS49B, and UICS50AG.
During an internal investigation, American Contract Systems found that some components were added without proper testing for heat and sterilization exposure.
Check the kit label for the model number and expiration date to see if it's affected. If it is, contact American Contract Systems for further instructions.
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-0830-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0830-2024 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.
