American Contract Systems recalls specific cardiac central line insertion kits with potential sterilization issues affecting functionality and drug efficacy. Affected kits include LLCE52, UICL44N, and UIPL77K models.
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 three cardiac central line insertion kits (LLCE52, UICL44N, UIPL77K) because components were improperly sterilized, which could cause loss of function or reduced drug effectiveness. This affects healthcare providers using these kits for medical procedures.
The kits were sterilized without proper assessment of components that were 'piggybacked' onto the trays. This could lead to components losing functionality or having higher than intended sterilant residues, potentially reducing drug effectiveness or causing improper medical procedures.
Healthcare providers using the recalled cardiac central line insertion kits for medical procedures are most at risk. The specific kits are used in hospitals and clinics for critical patient care.
Check for kits labeled as Central Line Insertion Packs with model numbers LLCE52, UICL44N, or UIPL77K. The lot numbers and expiration dates listed in the recall notice indicate specific batches affected.
Look for model numbers LLCE52, UICL44N, or UIPL77K on the kit packaging or labels.
The recall indicates potential issues with sterilization, but the kits are not unsafe to use. The manufacturer recommends checking the model numbers and lot numbers to confirm if they are affected.
The recall does not specify a remedy, so the official notice does not provide instructions for action. You should check the model numbers and lot numbers to determine if your kits are affected.
Check for model numbers LLCE52, UICL44N, or UIPL77K with specific lot numbers and expiration dates listed in the recall notice.
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-0819-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0819-2024 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.
