American Contract Systems, Inc. Sub Q Recorder Pack, REF BPRC87A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sub Q Recorder Pack, REF BPRC87A
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
UDI/DI 00191072187970, Lot Numbers: 969231
Products Sold
UDI/DI 00191072187970, Lot Numbers: 969231
American Contract Systems, Inc. is recalling Sub Q Recorder Pack, REF BPRC87A due to During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026