American Contract Systems recalls heart anesthesia kits with potential ineffective components due to improper sterilization. Affected kits include 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 heart anesthesia kits and central line insertion kits that may have components that don't work properly or lose drug effectiveness because they were sterilized incorrectly. This could affect medical procedures if the kits are used without the proper components.
The kits were assembled with components that were not properly tested for heat and sterilization exposure. This could lead to components losing functionality or drug effectiveness, potentially affecting medical procedures.
Healthcare professionals using the specific heart anesthesia kits and central line insertion kits with the listed model numbers and expiration dates are most at risk. Patients receiving procedures using these kits could be affected if the components don't function as intended.
Check for kit model numbers LMHA01V (heart anesthesia) or UIAN43L (central line insertion) with specific lot numbers and expiration dates listed in the recall notice.
Identify the kit model numbers (LMHA01V or UIAN43L) and associated lot numbers and expiration dates to determine if your kit is affected.
The affected kits are the Heart Anesthesia Bundle NS (model LMHA01V) and the Or/Anesthesia Central Line Insertion Kit (model UIAN43L) with specific lot numbers and expiration dates.
The recall is due to components being improperly sterilized, which may cause loss of functionality or drug effectiveness in the kits.
No, the recall does not require immediate discontinuation; affected users should check the model numbers and lot numbers to determine if their kits are 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-0816-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0816-2024 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.
