American Contract Systems recalls Baby PICC Kits (UIBP90J/K) and Pediatric PICC Kits due to potential loss of drug efficacy from improper sterilization. Affected kits may not function correctly or have higher chemical residues.
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 Baby PICC Kits and Pediatric PICC Kits that were sterilized without proper testing for the added components. This could lead to reduced drug effectiveness or kit malfunction in medical use.
The kits were sterilized without verifying that added components could withstand the heat and sterilization process. This might cause the components to lose function or reduce drug effectiveness, potentially leading to less effective medical treatments.
Healthcare facilities using Baby PICC Kits (UIBP90J/K) or Pediatric PICC Kits (UIPP76K) are most at risk. Patients receiving these kits may experience reduced drug efficacy if the kits are used without proper testing.
Check for kit numbers UIBP90J, UIBP90K, or UIPP76K on the product. The kits were sold with specific lot numbers and expiration dates listed in the recall notice.
Identify the kit number on the product label to determine if it is affected (UIBP90J, UIBP90K, or UIPP76K).
The recall is due to components being added to the kits without testing if they can withstand the sterilization process, which may cause reduced drug efficacy or kit malfunction.
Check the kit number and expiration date on the product. If it matches the affected models, contact American Contract Systems for further instructions.
The recall addresses potential reduced drug effectiveness, but no immediate safety risks to patients have been reported.
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-0826-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0826-2024 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.
