Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates a reasonable probability of serious health consequences. Per the rubric, FDA Class I recalls receive a Critical severity rating regardless of whether harm has been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject 35 mL Syringe Luer-Lock Tip Soft Pack due to demonstrated recognition and compatibility issues with syringe infusion pumps. The recalled syringes have lot numbers 221201, 230201, 230601, and 230602. Approximately 1,097,048 units were distributed nationwide to medical facilities across all U.S. states and territories.
The FDA classified this recall as Class I because infusion pumps may fail to properly recognize the syringes or may not be fully compatible with them, potentially resulting in device malfunction or medication delivery errors.
Patients and healthcare providers using affected syringes should stop use and contact their supplier or Cardinal Health for replacement. Affected syringes can be identified by lot numbers 221201, 230201, 230601, and 230602, or by their UDI/DI codes (10192253034691 for each unit, 20192253034698 for box, 50192253034699 for case).
The recalled product
- Product
- Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- pump-incompatibility
- recognition-failure
- medication-delivery-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Product Code: 1183500777
- UDI/DI: 10192253034691 - each
- 20192253034698 - box
- 50192253034699 - case
- Lot Numbers: 221201
- 230201
- 230601
- 230602
Distribution
Distributed nationwide across the United States.
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