American Contract Systems recalls sterile biopsy kits that may have components that don't work properly or have residual chemicals after sterilization. Affected kits have specific labels and lot numbers.
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 certain sterile biopsy kits that may have components that don't function correctly or have leftover chemicals from sterilization. This could affect the kits' effectiveness and safety during medical procedures.
The kits were assembled with components that weren't properly tested for heat and sterilization exposure. This could lead to components failing or having leftover chemicals that might affect treatment outcomes.
Healthcare professionals using these kits for procedures like biopsies or urological surgeries are most at risk. Patients using these kits may experience reduced effectiveness of treatments.
Look for kits labeled 'AHN BIOPSY STERILE' with model number AHBP12A. Check lot numbers: 963231 (expires 1/21/2024), 940231 (expires 1/21/2024), or 996231 (expires 2/28/2023).
Look for the label 'AHN BIOPSY STERILE' and model number AHBP12A on the kit.
The recall states that components may not function properly or have higher than specified sterilant residues, so they are not recommended for use.
The recall does not specify a remedy, so you should contact American Contract Systems for guidance.
Check for the label 'AHN BIOPSY STERILE' with model number AHBP12A and lot numbers 963231, 940231, or 996231.
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-0821-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0821-2024 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.
