CVS PCSU SJH, REF SJCV48J
FDA device recall Z-0175-2024 · posted 2023-10-26 · Open, Classified
Recall details
- Recalling firm
- American Contract Systems, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 36 cases
- Distribution
- US Nationwide distribution in the states of FL, IA.
- Date initiated
- 2023-09-01
- Date posted
- 2023-10-26
- Location
- Temple Terrace, FL
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