American Contract Systems recalls urology procedural kits (HGUR87G, LVCY20, LVUR44) due to potential loss of functionality or drug efficacy from improper sterilization. Affected kits may have higher than specified EO residuals.
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 urology procedural kits that may have lost functionality or drug efficacy because they were improperly sterilized. This could affect medical procedures and patient safety.
The kits were found to have components that were not properly assessed for heat and sterilization exposure. This could lead to loss of functionality, reduced drug effectiveness, or higher levels of ethylene oxide (EO) residuals than specified.
Healthcare providers using the recalled urology kits are most at risk, particularly those in hospitals or clinics that use these kits for procedures. Patients receiving treatments with these kits may also be affected.
Check for kit labels with model numbers HGUR87G (Urology DAVINCI Pack), LVCY20 (Cysto Pack), or LVUR44 (Uro Robotic Pack). The kits have specific expiration dates listed in the recall notice.
Look for model numbers HGUR87G, LVCY20, or LVUR44 on the kits to identify affected items.
The kits may have lost functionality, reduced drug efficacy, or higher than specified ethylene oxide residuals due to improper sterilization.
Check for model numbers HGUR87G (Urology DAVINCI Pack), LVCY20 (Cysto Pack), or LVUR44 (Uro Robotic Pack) on the kits.
No, but you should check if you have the recalled kits and contact the manufacturer if needed.
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-0823-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0823-2024 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.
