HIGH

American Contract Systems IHDC30R D AND C PACK Medical Kits Recalled Over Re-Gassing (32,433 Units,

American Contract Systems recalled the IHDC30R D AND C PACK medical convenience kits distributed nationwide in the United States. The recall stems from a nonconformance during Ethylene Oxide gas injection that led to re-gassing. The products have not been validated for exposure to multiple sterilization cycles. Health safety cannot be confirmed for re-gassed units. Stop using them and await recall

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
American Contract Systems
Category
Health & Personal Care
Sold At
Multiple Retailers
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

These are medical convenience kits used in clinical settings. They are intended to support routine medical workflows and patient care.

Why This Is Dangerous

Re-gassing after the EO sterilization process was not validated for multiple cycles. This raises concerns about the device meeting intended safety and effectiveness standards.

Industry Context

This recall is not presented as part of a broader industry pattern in the available information.

Real-World Impact

Hospitals and clinics may need to halt use of affected lots and coordinate with suppliers for replacement options. The recall may affect care delivery relying on these kits.

Practical Guidance

How to identify if yours is affected

  1. Confirm model IHDC30R UDI-DI 191072226310
  2. Check lot number 8096511
  3. Check bag serial number; if N/A, the whole lot is affected
  4. Compare to recall notice and FDA report

Where to find product info

Recall notices, FDA enforcement page Z-0187-2026, and manufacturer instructions

What timeline to expect

No refunds info provided in the data; follow the recall notification by letter for guidance on next steps

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • Contact FDA CPSC for guidance on consumer rights
  • Document communications and seek escalation if no response from manufacturer

How to prevent similar issues

  • Verify sterilization validation with suppliers
  • Ask manufacturers for EO sterilization validation data
  • In future purchases, require EO sterilization validation and lot-specific documentation

Documentation advice

Keep copy of recall notices, lot numbers, model numbers, and correspondence with manufacturer

Product Details

IHDC30R D AND C PACK medical convenience kits. Model: IHDC30R UDI-DI 191072226310. Lot: 8096511. Bag serial: N/A (bag serial listed as N/A means the whole lot is affected). Sold in the US nationwide with distribution in SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Manufacturer: American Contract Systems Inc.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 total units recalled
  • Recall date 2025-09-04; report date 2025-10-22
  • Distribution states: SD, IA, MN, WA, IL
  • Model: IHDC30R UDI-DI 191072226310
  • Lot: 8096511; bag serial number N/A indicates whole lot affected
  • Hazard: re-gassed EO sterilized after nonconformance; not validated for multiple cycles
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMedical convenience kit
Sold At
Multiple Retailers

Product Details

Model Numbers
IHDC30R UDI-DI 191072226310 lot 8096511 bag serial number N/A
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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