American Contract Systems recalls Sub Q Recorder Pack REF BPRC87A due to potential loss of drug efficacy from improper sterilization. Affected units have UDI/DI 00191:1072187970 and Lot Numbers 969231.
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 Sub Q Recorder Packs with reference number BPRC87A because the components may have lost drug efficacy due to improper sterilization. This could affect the effectiveness of medications administered through these devices.
The components in the Sub Q Recorder Pack were exposed to higher temperatures and ethylene oxide (EO) gas during sterilization than approved by the manufacturer. This could lead to reduced drug efficacy or loss of functionality in the device.
Healthcare professionals using Sub Q Recorder Packs with reference number BPRC87A are most at risk. Patients receiving medication via these devices may experience reduced efficacy if the pack is improperly sterilized.
Check for the reference number BPRC87A on the Sub Q Recorder Pack. Affected units have UDI/DI 00191072187970 and Lot Numbers 969231.
Verify the reference number BPRC87A and UDI/DI 00191072187970 on the device.
The components may have lost drug efficacy due to improper sterilization during the manufacturing process.
Check for reference number BPRC87A and UDI/DI 00191072187970 on the device. Affected units have Lot Numbers 969231.
The recall does not specify a remedy, so contact American Contract Systems for further instructions.
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-0180-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0180-2024 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.
