American Contract Systems recalls General Pack REF BBGP31C due to potential reduced drug efficacy from improper sterilization. Affected units have UDI/DI 00191:72166609 and Lot 968231. Consumers should contact for details.
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 recalls a specific medical packaging product (General Pack REF BBGP31C) because parts were sterilized incorrectly, which might make medications less effective. This could affect patients using the product for treatments.
The medical components in the pack were exposed to higher temperatures and EO gas during sterilization than they should have been. This could cause the parts to stop working properly or reduce the effectiveness of medications.
Patients using the General Pack REF BBGP31C for medical treatments are most at risk. The recall affects units with UDI/DI 00191072166609 and Lot Number 968231.
Check for the product name 'General Pack' with reference number BBGP31C. Affected units have UDI/DI 00191072166609 and Lot Number 968231.
Reach out to American Contract Systems for specific instructions on how to handle the recalled product.
The components were sterilized incorrectly, which might reduce medication effectiveness.
Contact American Contract Systems for specific instructions on handling the recalled product.
The recall addresses potential reduced drug efficacy, not immediate safety risks like injury.
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-0171-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0171-2024 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.
