American Contract Systems recalls heart catheterization trays (kit numbers JRHC45G, LLTV10, etc.) due to possible loss of functionality from improper sterilization. Affected units have specific 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 heart catheterization trays and related kits because some components were not properly tested for sterilization. This could lead to parts not working correctly or reduced effectiveness of medications. If you own any of these kits, you should check the lot numbers and expiration dates listed in the recall.
The recall involves components that were 'piggybacked' onto the trays during sterilization without proper testing. This could cause parts to lose functionality or reduce medication effectiveness, but it does not pose an immediate risk of injury or death.
Healthcare professionals who use heart catheterization trays and related kits in medical procedures are most at risk. Patients receiving these procedures may be affected if the kits are used without proper functionality.
Check for kit numbers: JRHC45G (heart catheterization tray), LLTV10 (TAVR pack), SJCA21F, SJCH22F, or UDIR58AL (interventional radiology ports). Look for specific lot numbers and expiration dates listed in the recall notice.
Identify the kit number on your product (e.g., JRHC45G, LLTV10) and compare with the list of affected models provided in the recall.
Check the expiration date on the product's lot number to see if it matches the affected dates listed in the recall notice.
During an internal investigation, American Contract Systems found that some components were not properly tested for sterilization, which could lead to loss of functionality or reduced medication effectiveness.
Heart catheterization trays (kit number JRHC45G), TAVR packs (kit number LLTV10), and other related kits with specific lot numbers and expiration dates listed in the recall notice.
No, the recall does not require immediate discontinuation. However, you should check the kit numbers and expiration dates to determine if your product is affected.
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-0817-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0817-2024 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.
