Cath Cardiac Pack, REF IHCC03V
Reported: November 1, 2023 Initiated: September 1, 2023 #Z-0182-2024
Product Description
Cath Cardiac Pack, REF IHCC03V
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.
Details
- Recalling Firm
- American Contract Systems, Inc.
- Units Affected
- 1260 units
- Distribution
- US Nationwide distribution in the states of FL, IA.
- Location
- Temple Terrace, FL
Frequently Asked Questions
What product was recalled? ▼
Cath Cardiac Pack, REF IHCC03V. Recalled by American Contract Systems, Inc.. Units affected: 1260 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0182-2024.
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