HIGH

American Contract Systems High-Index Medical Kits Recalled for Re-Gassing After EO Sterilization Non

American Contract Systems recalled 32,433 medical convenience kits nationwide in the United States after re-gassing sterilization cycles. The recall covers multiple packs including HEART PACK and PACEMAKER PACK with 2025 recall date. The safety issue centers on EO gasset validation failures after a nonconformance during initial gas injection. Stop using immediately and follow recall instructions.

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

Medical kits used in clinical settings to supply cardiovascular procedures. They can include heart packs, CV setup packs, pacemaker packs, and vascular packs.

Why This Is Dangerous

Re-gassing after EO sterilization may affect sterility and effectiveness. Validation for multiple cycles is lacking.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics may need to quarantine affected lots and reassess inventory impact.

Practical Guidance

How to identify if yours is affected

  1. Review item numbers and UDIs listed in recall.
  2. Check bag serial numbers where available.
  3. Cross-reference with distributor records.

Where to find product info

FDA enforcement page and recall notice; UDI-DI codes on packaging

What timeline to expect

Refunds or replacements processed through hospital procurement; typical timelines vary by institution

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • Contact FDA or CPSC for guidance
  • Consult legal counsel if needed

How to prevent similar issues

  • Implement single-cycle validated EO sterilization for kits
  • Post reminders to procurement about sterilization validation
  • Keep detailed records of sterilization cycles and lot numbers

Documentation advice

Keep product invoices, batch numbers, serials, and recall communications

Product Details

Item numbers and descriptions include ANCV78BC HEART PACK 205947, HGCV05K CV SET UP PACK, MHPP97AR PACEMAKER PACK 206010, UDBH37AW BASIC HEART PACK 206044, UHPP82AH PERIPHERAL PACK 209533, UICD62AN CARDIOVASCULAR SUPPLY PS 907285, UICT16F CARDIO THORACIC DRAPE PACK PS 907284, UIVA75I VASCULAR PACK. Total quantity: 32,433 units. Distribution: US nationwide in SD, IA, MN, WA, IL.

Reported Incidents

No injury data provided in the recall notice. The FDA enforcement report lists the status as active with high hazard level.

Key Facts

  • 32,433 total units recalled
  • High hazard level
  • Re-gassed after EO sterilization
  • Not validated for multiple sterilization cycles
  • Distributed nationwide in SD, IA, MN, WA, IL
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 TypeSterilization-reused medical kits
Sold At
Unknown

Product Details

Model Numbers
ANCV78BC
ANCV78BB UDI-DI 191072214362
HGCV05K
MHPP97AR
UDBH37AW
+5 more
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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