American Contract Systems, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0182-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Cath Cardiac Pack, REF IHCC03V

Product Classification:

Class II

Date Initiated: September 1, 2023

Date Posted: November 1, 2023

Recall Number: Z-0182-2024

Event ID: 93086

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.

Status: Ongoing

Product Quantity: 1260 units

Code Information:

UDI/DI 00191072189431, Lot Numbers: 724221, 679221, 945231

Distribution Pattern:

US Nationwide distribution in the states of FL, IA.

Voluntary or Mandated:

Voluntary: Firm initiated