HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
American Contract Systems Recalls Radiology Packs Over Sterilization Issues
American Contract Systems recalled 32,433 radiology packs on September 4, 2025, due to improper sterilization. The products were re-gassed after a nonconformance in the initial Ethylene Oxide gas injection process. Their safety and effectiveness remain unverified after multiple sterilization cycles.
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 affects the LKRA40G Radiology Pack. These kits were distributed nationwide in states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
The Hazard
The products were not validated for exposure to multiple sterilization cycles, which raises significant safety concerns. Quality, safety, and effectiveness cannot be assured for the re-gassed items.
Reported Incidents
No specific injuries or incidents have been reported related to this recall. The potential risks associated with improper sterilization could pose serious health threats to patients.
What to Do
Stop using the radiology packs immediately. Follow the recall instructions provided by the manufacturer and contact American Contract Systems or your healthcare provider for further guidance.
Contact Information
For assistance, contact American Contract Systems Inc. directly. Additional information can be found on the FDA website.
Key Facts
- Recall date: September 4, 2025
- Quantity affected: 32,433 units
- Distribution: Nationwide in specific states
- Hazard: Improper sterilization cycles
- Classification: Class II
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Safety Assessment
Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeMedical Convenience Kits
Sold At
Multiple Retailers
Product Details
Categories
Model Numbers
LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347 * If bag serial number is listed as "N/A"
then whole lot is affected
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
SUCRALFATE
CGMP Deviations:
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Labeling: Incorrect or Missing Lot and/or Exp Date
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