FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support product sterility claims.
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, and the hazard involves a risk of harm (infection) from non-sterile medical devices, even though no specific injuries are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for hypodermic needles manufactured by International Medsurg Connection, Inc. The recall involves 54,204,100 units of 27 G x 1.0 in DISP HYPO needles, packaged 100 per box and 50 boxes per case. The product is used to inject fluids into, or withdraw fluids from, the body for diagnosis or treatment purposes.
The recall was initiated because the manufacturer has insufficient documentation to support the product's sterility claims. The affected needles were distributed nationwide, including in Ohio, Massachusetts, Georgia, Florida, North Carolina, Mississippi, Missouri, Pennsylvania, Indiana, New Jersey, Texas, Kansas, Louisiana, Nebraska, Washington, Alabama, Utah, Alaska, California, Illinois, Minnesota, Maryland, New York, and Michigan.
Healthcare facilities and distributors should stop using the affected needles and contact the manufacturer for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 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.
- 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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- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
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