Moderate FDA (Devices)·Z-2811-2017·Announced 2017-08-16

FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient 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 for sterility claims without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

International Medsurg Connection, Inc. is recalling specific lots of Hypodermic Needles (20 G X 1.5 in BD YALE DISP RG) under FDA recall number Z-2811-2017. The recall is being conducted because the firm has insufficient documentation to support the product's sterility claims. 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 involves 54,204,100 units of the needles. The products were distributed nationwide, including to facilities 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. Specific lot numbers are listed in the official FDA recall notice.

Healthcare facilities and consumers who have these products should stop using them and contact International Medsurg Connection, Inc. for instructions on how to return the products for a refund or replacement.

The recalled product

Product: Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 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, treatme
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Hypodermic Needles
Hazard: sterility-documentation
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
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FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
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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 · sterility documentation