Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect
Cardinal Health is recalling 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 compromised sterility barrier, which poses a risk of harm (infection) but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject Standard Hypodermic Needles, 16 G x 1-1/2" (Item code: 8881200045). The recall is limited to Lot Number 905613.
The recall was initiated because a manufacturing defect was found in the cartridge component. This defect could compromise the sterility barrier of the product, potentially affecting the safety of the needles.
The affected products were distributed nationwide and in foreign countries including Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands. Consumers and healthcare providers should stop using the affected needles and contact Cardinal Health for further instructions or a replacement.
The recalled product
- Product
- Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
- 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 (1)
- Lot Number: 905613
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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