American Contract Systems recalls custom hospital procedural kits due to potential incompatibility with sterilization processes, risking loss of function or drug efficacy. Affected kits include IR NEURO PACK and others with specific kit 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 custom hospital procedural kits that may have components not properly tested for sterilization. This could lead to loss of function or reduced drug effectiveness in medical use.
During an internal investigation, ACS found that some components were added to their trays without proper testing for sterilization. This could cause the components to lose function or have reduced drug effectiveness, especially if used in medical procedures.
Healthcare facilities using these specific hospital kits for procedures like neurosurgery or craniotomies. Staff handling these kits during surgeries or medical procedures are at risk.
Check if your kit has a label with the product name (e.g., IR NEURO PACK) and a kit number listed in the recall. The specific kit numbers and expiration dates are provided in the recall notice.
Look for the product name and kit number on the kit label to determine if it's affected.
The recall includes specific hospital kits like IR NEURO PACK (kit number AGNE20J), ADULT CRANIOTOMY PACK (kit number LLCR99), and others with listed kit numbers and expiration dates.
American Contract Systems identified that some components were added to their trays without proper testing for sterilization, which could lead to loss of function or reduced drug effectiveness.
No immediate stop is required; the recall is for review and potential replacement, not an urgent stop.
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-0827-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0827-2024 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.
