American Contract Systems recalls breast plastics procedure kits with potential loss of functionality due to improper sterilization process. Affected kits 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 breast plastics procedure kits that may have lost functionality or drug efficacy because they were improperly sterilized. This could affect the kits' performance during medical procedures.
The kits were assembled with components that were not properly tested for heat exposure during sterilization. This could lead to components losing functionality or having higher than intended sterilant residues, potentially affecting medical procedures.
Surgical teams using the breast plastics procedure kits with specific lot numbers and expiration dates are most at risk. Patients undergoing breast plastic surgery may be affected if the kits are used without proper functionality.
Check for kit numbers BBPL20D or WPMP16H with specific lot codes listed in the recall notice. The kits were sold with expiration dates ranging from 2023 to 2024.
Identify if your kit has the model numbers BBPL20D or WPMP16H with the listed lot codes.
The kits may have lost functionality or drug efficacy due to improper sterilization testing, which could affect medical procedures.
Check for kit numbers BBPL20D or WPMP16H with specific lot codes listed in the recall notice.
No, the recall is for potential issues with functionality, not an immediate safety hazard requiring immediate stop use.
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-0824-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0824-2024 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.
