Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect
Cardinal Health 200, LLC is recalling Monoject Blunt Cannula, 20 G x 1-1/2" (Item code: 8881202363), because a manufacturing defect in the cartridge component 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 to the sterility barrier, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm), Item code: 8881202363. The recall is due to a manufacturing defect found in the cartridge component, which could compromise the sterility barrier of the product.
The affected product is identified by Lot Number: 907734. The product was distributed nationwide and in the following foreign countries: AU, BE, CA, DK, FI, GB, IE, and NL.
Healthcare facilities and consumers should stop using the affected product and contact Cardinal Health 200, LLC for further instructions or a return.
The recalled product
- Product
- Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringe/Cannula
- Hazard
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 (1)
- Lot Number: 907734
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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