Moderate FDA (Devices)·Z-2822-2017·Announced 2017-08-16

FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

International Medsurg Connection is recalling 54.2 million hypodermic needles because documentation supporting their sterility claims is insufficient.

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 due to insufficient documentation supporting sterility claims, which fits the rubric for moderate severity involving documentation issues or theoretical risks without reported injuries.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for International Medsurg Connection, Inc. hypodermic needles. The recall involves 54,204,100 units of 27 G x 1.5 in hypodermic needles, catalog number N3602715. These products are used to inject fluids into, or withdraw fluids from, the body for the diagnosis, cure, mitigation, treatment, or prevention of disease.

The reason for the recall is insufficient documentation to support product sterility claims. The 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 recalling firm for instructions on return or disposal. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 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.
Category: Medical Device — Needles
Hazard: documentation-deficiency
sterility-uncertainty
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

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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 →

Same manufacturer · International Medsurg Connection, Inc.

See all →

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FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Moderate
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
FDA (Devices) · 2017-08-16
High
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Moderate
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Moderate
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16

Same hazard · documentation deficiency