Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect
Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas due to a manufacturing defect that could compromise the product's sterility barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is voluntarily recalling Monoject Blunt Cannula, 19 G x 1-1/2" (Item code: 8881202355). The recall is being conducted because a manufacturing defect was identified in the cartridge component, which could compromise the sterility barrier of the product.
The affected lots are 905617, 905618, 905619, 905620, 907004, and 907005. The products were distributed nationwide and in foreign markets including Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands.
This recall is classified as Class II by the FDA. Users should stop using the affected products and contact Cardinal Health 200, LLC for further instructions or a return.
The recalled product
- Product
- Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
- Manufacturer
- Cardinal Health 200, LLC
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 (6)
- Lot Number: 905617
- 905618
- 905619
- 905620
- 907004
- 907005
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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