Recall Z-0180-2024— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2023-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Sub Q Recorder Pack, REF BPRC87A. Reason: 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..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-01
- Firm location
- Temple Terrace, FL, United States
Product description
Sub Q Recorder Pack, REF BPRC87A
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.