FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling hypodermic needles because the company lacks documentation to support the products' sterility claims.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites insufficient documentation rather than confirmed contamination or reported injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
International Medsurg Connection, Inc. is recalling specific lots of Hypodermic Needles (25 G X 1.0 in REG BEVEL) under FDA recall number Z-2817-2017. The recall is being conducted because the firm has insufficient documentation to support the product sterility claims for these devices.
The affected products are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The recall covers 54,204,100 units distributed nationwide, including states such as Ohio, Massachusetts, Georgia, Florida, and New York.
Healthcare providers and facilities should stop using the affected needles and contact the recalling firm for instructions on how to return or dispose of the products. Consumers should not use these needles if they have them in their possession.
The recalled product
- Product
- Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
- Manufacturer
- International Medsurg Connection, Inc.
- Hazard
- Affected units
- 54,204,100
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 (20)
- 12-6925-x
- 12-6968-x
- 12-7060-x
- 12-7119-x
- 12-7144-x
- 12-7177-x
- 12-7208-x
- 12-7258-x
- 12-7259-x
- 12-7324-x
- 12-7325-x
- 12-7363-x
- 12-7391-x
- 12-7412-x
- 12-7463-x
- 12-7469-x
- 12-7472-x
- 12-7499-x
- 13-6780-x
- 13-7538-x
Distribution
Part of a larger recall action
This product is one of 59 recalled by International Medsurg Connection, Inc. 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.
See all 59 products in this recall →Related recalls
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