HIGH

American Contract Systems Recalls 32,433 Cardiac Cath Lab Kits Due to Re-Gassed Sterilization Risk (

American Contract Systems recalled 32,433 cardiac cath lab kits distributed nationwide to healthcare providers. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. The kits have not been validated for exposure to multiple sterilization cycles and cannot be guaranteed safe.

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
American Contract Systems
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

Medical convenience kits are used in cath lab procedures and include packs for left heart caths and angiography. They are designed for single-use in sterile environments.

Why This Is Dangerous

Re-gassing after EO sterilization may compromise sterility and device performance if cycles exceed validated limits.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals may experience procedure delays or require alternate supplier arrangements while affected kits are identified and replacement materials are provided.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers AMCL05P, EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH.
  2. Review UDI-DI data, lot numbers, and bag serial numbers shown in the recall listing.
  3. Quarantine any units that match the recall details.

Where to find product info

UDI-DI is printed on packaging; lot numbers and bag serial numbers are on the bag labels.

What timeline to expect

4-8 weeks for replacement or remediation after recall initiation.

If the manufacturer is unresponsive

  • Escalate to hospital recall coordinator and consider contacting FDA MedWatch if no response.
  • Document all outreach attempts and responses.

How to prevent similar issues

  • Require sterilization processes to be validated for multiple cycles before use.
  • Ask suppliers for EO sterilization validation documentation.
  • Implement a robust inventory check to identify affected lots quickly.

Documentation advice

Keep recall letter, product labels, UDI-DI, lot numbers, and bag serial numbers. Photograph packaging and maintain an inventory list.

Product Details

Model numbers include EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH, and AMCL05P. Items described as LEFT HEART CATH PACK, CATH LAB ANGIO, CATH CARDIAC PACK, CARDIAC CATH TRINITY, CARDIAC CATH ANGIO PACK, and RADIAL PACK. US nationwide distribution to healthcare providers, with state distribution listed as SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Quantity: 32,433 units. Manufacturer: American Contract Systems. No consumer retailers identified. Price information not provided.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 total units recalled
  • Models: AMCL05P, EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH
  • Nationwide distribution to SD, IA, MN, WA, IL
  • Recall date 2025-09-04; Report date 2025-10-22
  • No injuries or incidents reported
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCardiac Catheterization Kit
Sold At
Unknown

Product Details

Model Numbers
AMCL05P
EVLH67F
FDCL22R
IHCC03X
TNCC02AD
+2 more
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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