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Open, Classified

Pediatric Heart SJH, REF SJPH34K

FDA Recall Z-0176-2024 · Posted 2023-10-26

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2023-09-01
Product Quantity72 cases

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.

Firm Action

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

Distribution Pattern

US Nationwide distribution in the states of FL, IA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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