Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect
Cardinal Health 200, LLC is recalling specific lots of Monoject Standard Hypodermic Needles 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 involves a risk-of-harm product (medical device) where a defect could compromise sterility, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject Standard Hypodermic Needles, 16 G x 1-1/2" (Item code: 8881200037). The recall affects lot numbers 904212, 905612, and 907002. The product was distributed nationwide and in foreign markets including Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands.
The recall was initiated because a manufacturing defect was found in the cartridge component of the needles. This defect could compromise the sterility barrier of the product, potentially affecting the safety of the medical device.
Healthcare providers and consumers should stop using the affected needles and contact Cardinal Health 200, LLC for further instructions or a return.
The recalled product
- Product
- Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Needles
- 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 (3)
- Lot Number:904212
- 905612
- 907002
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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