Reported Nov 1, 2023 · Ongoing
Sub Q Recorder Pack, REF BPRC87A
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 7802 E Telecom Pkwy · Temple Terrace, FL · 33637-0928
Is this the product you have?
- Sub Q Recorder Pack, REF BPRC87A
- Lot codes and dates
- UDI/DI 00191072187970
- Lot Numbers969231
- Amount recalled
- 96 cases
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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