HIGH

American Contract Systems Recalls Medical Kits Over Safety Risk

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. These kits failed to meet safety standards due to improper sterilization processes. The recall affects multiple states, including South Dakota and Iowa.

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

Product Details

The recall includes various medical convenience kits such as the LEFT HEART CATH PACK (Item Number EVLH67F) and others. The affected products were distributed nationwide in states including SD, IA, MN, WA, and IL.

The Hazard

The products were re-gassed after a nonconformance during the Ethylene Oxide gas injection process. These items have not been validated for exposure to multiple sterilization cycles, raising concerns about their quality and effectiveness.

Reported Incidents

No specific injuries or incidents have been reported. However, the risk associated with using these unvalidated sterilized products remains high.

What to Do

Stop using the recalled medical kits immediately. Follow the recall instructions provided by the manufacturer and contact American Contract Systems for further information.

Contact Information

For further details, contact American Contract Systems at the phone number provided in the recall notification. Additional information can be found on the FDA website.

Key Facts

  • Recall date: September 4, 2025
  • Total units recalled: 32,433
  • Sold in multiple states: SD, IA, MN, WA, IL
  • Class II recall due to safety concerns
View Original Recall on FDA - Medical Devices

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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
Multiple Retailers

Product Details

Model Numbers
AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68194176 68194179 68194182 68194190 Lot 8526511 Bag serial numbers 68873157 68874410
EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438
FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376
IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761
TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615
+3 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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