HIGH

American Contract Systems Medical Convenience Kits Recalled for Re-Gassing Risk

American Contract Systems recalled 32,433 medical convenience kits after it was discovered they were re-gassed after sterilization failure. The sterilization process may compromise the product's quality, safety, and effectiveness. Healthcare providers must stop using these kits immediately and follow up with the manufacturer for 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

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 healthcare settings for various procedures requiring sterile equipment. They are essential for ensuring patient safety during surgeries and treatments.

Why This Is Dangerous

The re-gassing of these kits after an initial sterilization failure means they have not been properly validated for safety, potentially leading to ineffective products being used in medical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers face potential health risks if these medical kits are used, as their effectiveness cannot be guaranteed due to compromised sterilization processes. Immediate action is necessary to prevent harm.

Practical Guidance

How to identify if yours is affected

  1. Check the model number of your medical convenience kit against the affected list.
  2. Look for any lot numbers or bag serial numbers on the packaging.
  3. Discard any kits that match the recalled models.

Where to find product info

Serial numbers and lot numbers are typically found on the product packaging or insert.

What timeline to expect

Expect a timeline of 4-8 weeks for refunds or replacements.

If the manufacturer is unresponsive

  • Document all communication attempts with the manufacturer.
  • File a complaint with the FDA or relevant consumer safety agency.

How to prevent similar issues

  • Buy medical devices from reputable manufacturers that provide clear sterilization validation.
  • Check for updated recalls regularly on manufacturer's websites.

Documentation advice

Keep records of all correspondence with the manufacturer and any related receipts or product information.

Product Details

Affected models include BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, UICY28L. These products were distributed nationwide in the U.S., particularly in SD, IA, MN, WA, and IL. Sold under the brand name American Contract Systems.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 units recalled
  • Risk of compromised sterilization
  • Affected models: BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, UICY28L
  • Sold in states: SD, IA, MN, WA, IL
  • Immediate action required: stop using & contact 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
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMedical Convenience Kits
Sold At
Unknown

Product Details

Model Numbers
BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421
CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370
IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124
MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A
PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184
+2 more
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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