Cath Cardiac Pack sterilization failure may cause loss of functionality
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device with potential loss of functionality and higher-than-specified ethylene oxide residuals. Per the severity rubric, it qualifies as a risk-of-harm product where injury has not yet been reported. FDA Class II classification and the potential for device failure in a cardiac application warrant High severity. No illnesses, injuries, or deaths have been reported.
Plain-English summary
American Contract Systems, Inc. is recalling 1260 units of Cath Cardiac Pack (REF IHCC03V) due to sterilization process failures. During an internal investigation, the company identified that the I.V. Catheter component (part number 4252535-02) and Adhesive Dermabond component (part number DHVM12) were inadvertently subjected to improper sterilization. The components were exposed to ethylene oxide (EO) gas and temperatures higher than those approved by the component manufacturer.
As a result of this improper sterilization exposure, the affected components may experience loss or lack of functionality, loss of drug efficacy where applicable, and may contain higher than specified ethylene oxide residuals. These conditions could compromise the safety and effectiveness of the cardiac pack.
The recall affects units with UDI/DI 00191072189431 and lot numbers 724221, 679221, and 945231. Distribution was made nationwide, with identified distribution in Florida and Iowa.
Healthcare facilities and patients who have these units should stop using them and contact American Contract Systems, Inc. for replacement or return instructions. Consult the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-0182-2024 for complete details.
The recalled product
- Product
- Cath Cardiac Pack, REF IHCC03V
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 1,260
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 00191072189431
- Lot Numbers: 724221
- 679221
- 945231
Distribution
Part of a larger recall action
This product is one of 12 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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