HIGH

American Contract Systems LKRA40G Radiology Pack Recalled Over Unvalidated Re-sterilization (HIGH)

American Contract Systems recalled 32,433 radiology packs after a nonconformance during EO gas injection. The items were re-gassed and not validated for multiple sterilization cycles. The recall is active as of 2025-10-22. US distribution included SD, IA, MN, WA, IL. Health risks prompt immediate removal from use.

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, PREGNANT, PETS

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

The LKRA40G Radiology Pack is a medical convenience kit used in radiology settings. Such kits support imaging processes and may contain sterile instruments or related supplies.

Why This Is Dangerous

The product was re-gassed after EO sterilization nonconformance. Multiple sterilization cycles have not been validated, risking compromised sterility and safety.

Industry Context

This recall is not indicated as part of a broader industry pattern in the provided data.

Real-World Impact

Immediate use cessation required; potential safety risk to patients and staff if sterility is compromised.

Practical Guidance

How to identify if yours is affected

  1. Locate model LKRA40G UDI-DI 191072189691 and Lot 8025211.
  2. Check bag serial number 68154347 or note N/A indicating entire lot.
  3. Refer to FDA recall Z-0182-2026 for official details.

Where to find product info

FDA enforcement page linked in recall notice; product labeling and hospital procurement records

What timeline to expect

Refund or replacement timing not specified; typical recall processing ranges 4-8 weeks depending on manufacturer

If the manufacturer is unresponsive

  • Escalate to FDA recall liaison
  • File report with hospital risk manager
  • Keep documentation of all communications

How to prevent similar issues

  • Ensure sterilization processes are validated for all cycles
  • Prefer single-cycle sterilization validated products
  • Verify EO sterilization parameters before procurement

Documentation advice

Retain packaging, labels, serial numbers, purchase records, and all correspondence with manufacturer

Product Details

Product: LKRA40G Radiology Pack. Brand: American Contract Systems. Model: LKRA40G UDI-DI 191072189691. Lot: 8025211. Bag serial: 68154347 (or N/A indicates entire lot). Quantity: 32,433. Distribution: United States (SD, IA, MN, WA, IL). Recall date: 2025-09-04. Status: ACTIVE.

Reported Incidents

No specific injuries or incidents reported in the provided data.

Key Facts

  • 32,433 total units recalled
  • Re-gassed after EO sterilization nonconformance
  • Not validated for multiple sterilization cycles
  • US distribution across SD, IA, MN, WA, IL
  • Recall issued 2025-09-04; FDA enforcement report Z-0182-2026
  • Stop use immediately; contact provider or manufacturer
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
GENERALPREGNANTPETS
Injury Types
ELECTRICALOTHER

Product Classification

Product TypeRadiology Pack
Sold At
Unknown

Product Details

Model Numbers
LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347
Lot 8025211
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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