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 Medical Kits Over Sterilization Issues
American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The products failed to meet sterilization standards, posing a safety risk. Healthcare providers and patients must stop using these kits immediately.
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 recalled medical convenience kits include models FHCP08Y, HICS50I, and HSCB90B. These items were distributed nationwide in states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
The Hazard
These medical kits underwent multiple sterilization cycles without validation. This failure raises concerns regarding their quality, safety, and effectiveness.
Reported Incidents
No specific incidents or injuries have been reported related to these products. However, the lack of validation for re-gassed kits presents a high risk.
What to Do
Stop using the recalled medical kits immediately. Follow the instructions provided by the manufacturer or contact your healthcare provider for further guidance.
Contact Information
For questions, contact American Contract Systems Inc. Additional information is available on the FDA website.
Key Facts
- Recall date: September 4, 2025
- Total quantity recalled: 32,433
- Class II recall due to safety risks
- Distribution includes SD, IA, MN, WA, IL
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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
Categories
Model Numbers
FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296
HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637
HSCB90B UDI-DI 191072141606 Lot 8083511 Bag serial numbers 47506618 47508489 * 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
Related Recalls
HIGH
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
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:
HIGH
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect