American Contract Systems recalls specific surgical kits for potential loss of functionality or drug efficacy after improper sterilization. Affected kits include LAP KIDNEY MODULE and others with listed lot 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 several surgical kits used in gastroenterology and urology procedures. These kits may have lost functionality or reduced drug effectiveness due to improper sterilization processes during manufacturing.
The kits were found to have components that were not properly assessed for heat and sterilization exposure. This could lead to components losing functionality or reducing the effectiveness of drugs if used in procedures.
Healthcare professionals using these kits in surgical procedures are most at risk. Patients receiving treatments with affected kits could experience reduced effectiveness of medications or improper surgical outcomes.
Check for kit numbers listed in the recall: AGKD50L, ANPR34S, BFLC02AD, and others. Look for specific lot numbers and expiration dates provided in the recall notice.
Identify the kit number on your product (e.g., AGKD50L, ANPR34S) and compare with the list provided in the recall.
The affected kit numbers include AGKD50L, ANPR34S, BFLC02AD, GUGE09I, HNLC80I, JSLC06I, LMLP08Z, MHRB88AJ, MMLP40F, MMML26F, OWLC07K, SAGL57H, SARB30K, SARB30L, SARB30M, SMLC53, SNRP85D, SSRO22C, SSRO22D, TPDV16, UICH53Y, and WVGL60E.
Check the kit number and lot number on your product against the list provided in the recall notice. Each kit has specific lot numbers and expiration dates listed.
The recall does not specify a remedy, so affected users should contact American Contract Systems directly for further instructions.
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-0822-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0822-2024 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.
