American Contract Systems recalls cardiac procedural kits and trays with specific kit numbers and lot dates due to possible component failure 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 cardiac procedural kits and trays that may have components that don't work properly or lose effectiveness after being exposed to sterilization. This could affect medical procedures involving these kits.
During an internal investigation, ACS found that some components were added to their trays without proper testing for sterilization. This could mean the components might not work correctly or lose their effectiveness after sterilization, potentially affecting medical procedures.
Healthcare professionals using these kits for cardiac procedures are most at risk. Patients receiving these kits during surgery may be affected if the kits are used without proper functionality.
Check for kit numbers listed in the recall: AGBI64J, AGDI40J, AGDI40K, AGMV26O, AGOH98Q, AGOH98R, AGOH98S, AGPV28O, AGPV28P, AHMV26J, AHMV26K, ANCV78AX, ANCV78AX1, ANHK74N, BHOH43, BHOP48, BHPM60, FBDI42K, FBDI42L, FBDI42M, FBTO60G, JROH00O, JROH98O, LLOH52, LLOP25, LLPP14, LMCB06AD, LMCH99O, LMOH50AD, LMOH50AD-01, LMOH50AD-02, LMOH50AE, MMCV98V, MMCV98V-03, MMCV98V-04, MMOH64J, MMPM27E, MMTR12F, NCAC96, NCOH11, SAVA91G, SAVA91H, SAVA91I, SAVA91J, SJOH17I, SJOH28L, SJPH34K, SJVO56A, SJVO56B, SVMJ20L, SVMJ20M, SVMN60J, SVOH38Q, TNCB10AK, UICD62AM. Also check for specific lot numbers and expiration dates listed in the recall.
Look for specific kit numbers listed in the recall to determine if your product is affected.
Reach out to American Contract Systems for more information about your specific kit and any necessary actions.
Cardiac procedural kits and trays with specific kit numbers and lot dates listed in the recall.
During an internal investigation, ACS found that some components were added to their trays without proper testing for sterilization, which could lead to components not working correctly or losing effectiveness.
Check for the specific kit numbers and lot numbers listed in the recall to determine if your product is affected.
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-0818-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0818-2024 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.
