American Contract Systems recalls 30+ surgical kits due to potential loss of function or drug efficacy from improper sterilization process.
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 over 30 different surgical kits that may have lost functionality or reduced drug effectiveness because they were improperly sterilized. This could affect medical procedures requiring these kits.
During an internal investigation, ACS found that some components were 'piggybacked' onto their trays and subjected to sterilization without proper testing. This could cause the components to lose functionality, reduce drug effectiveness, or have higher than specified sterilant residues.
Healthcare professionals using these kits in surgical procedures. Patients undergoing surgery with these kits may be at risk if the kits don't function properly or have reduced drug effectiveness.
These kits are labeled with specific names like 'BRACHY THERAPY PROCEDURE PAC' or 'MINOR MINOR AGH ASC PACK'. Check the kit number on the label (e.g., AGBR90E, AGMM60M) and the expiration date on the lot number.
Identify the kit number on the label (e.g., AGBR90E, AGMM60M) and compare with the list of affected kits in the recall notice.
The recall states that the components may have lost functionality or reduced drug effectiveness, but no specific safety risks are mentioned for normal use.
Check the kit number on the label (e.g., AGBR90E, AGMM60M) and compare with the list of affected kits provided in the recall notice.
The recall notice does not specify a return or remedy action, so no action is required beyond checking if the kit is on the list.
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-0825-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0825-2024 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.
