Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns
Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component 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. The hazard involves a potential compromise to the sterility barrier of a medical device, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject Standard Hypodermic Needles, 20 G x 1-1/2" bulk (Item code: 8881200664). The recall affects lot numbers 905657, 906327, and 906341. These products were 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 identified in the cartridge component. This defect could compromise the sterility barrier of the product, potentially affecting the safety of the needles.
Healthcare providers and consumers should stop using the affected lots immediately. Users should check their inventory for the specific lot numbers listed above and contact Cardinal Health for further instructions on returns or replacements.
The recalled product
- Product
- Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
- 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 (3)
- Lot Number: 905657
- 906327
- 906341
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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