American Contract Systems recalls Breast Plastics Pack REF BBPL20D due to potential loss of functionality and drug efficacy from improper sterilization. Affected units have specific lot numbers and UDI/DI codes.
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
American Contract Systems is recalling Breast Plastics Packs with reference number BBPL20D because the components may have lost functionality or reduced drug effectiveness due to improper sterilization. This could impact medical use if the device is not functioning correctly.
The components were exposed to higher temperatures and ethylene oxide (EO) gas during sterilization than approved by the manufacturer. This could cause the components to lose functionality or reduce drug effectiveness, potentially affecting medical procedures.
Medical professionals using Breast Plastics Packs for procedures are likely affected. Patients receiving these packs may be at risk if the device doesn't function as intended.
Check for the product reference number BBPL20D on the pack. Affected units have specific lot numbers: 756221, 782221, 862221, and UDI/DI code 00191072166241.
Identify the product reference number BBPL20D and check lot numbers 756221, 782221, or 862221 with UDI/DI code 00191072166241.
The components were exposed to higher temperatures and ethylene oxide gas during sterilization than approved by the manufacturer, which may cause loss of functionality or reduced drug effectiveness.
Check the product reference number and lot numbers to see if it's affected. If it is, contact American Contract Systems for further instructions.
The recall is due to potential loss of functionality or reduced drug effectiveness, not a risk of serious injury. The danger level is low risk.
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-0173-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0173-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
