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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a potential compromise of the sterility barrier, which is a risk-of-harm scenario where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is voluntarily recalling Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm), Item code 8881202322. 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 902110 and 902111. The product was distributed nationwide and in the following foreign countries: Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands.
Consumers and healthcare providers should stop using the affected product and contact Cardinal Health 200, LLC for further instructions or a replacement.
The recalled product
- Product
- Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
- 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 (2)
- Lot Number: 902110
- 902111
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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