Z-0171-2024 Class II Ongoing
FDA device recall Z-0171-2024 was initiated by American Contract Systems, Inc. on Sep 1, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 57 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 1, 2023
- Initiation Date
- Sep 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 cases
Product Description
General Pack, REF BBGP31C
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.
Distribution Pattern
US Nationwide distribution in the states of FL, IA.
Code Information
UDI/DI 00191072166609, Lot Number 968231
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0171-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026