Cardinal Health Monoject Hypodermic Needle Recall for Sterility Barrier Defect
Cardinal Health is recalling Monoject Standard Hypodermic Needles due to a manufacturing defect that could compromise the 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 involves a risk-of-harm product (medical device) where a defect could compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject Standard Hypodermic Needles (Item code: 8881200029, Lot Number: 904956). The recall was initiated because a manufacturing defect was found in the cartridge component, which could compromise the sterility barrier of the product.
The affected needles were distributed nationwide and in foreign markets including Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands. This recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare facilities should stop using the affected needles and contact Cardinal Health for further instructions or a replacement.
The recalled product
- Product
- Monoject Standard Hypodermic Needle Item code: 8881200029
- Manufacturer
- Cardinal Health 200, LLC
- 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: 904956
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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