High FDA (Devices)·Z-2812-2017·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 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 product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

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 is due to insufficient documentation to support product sterility claims. The affected products are 21 G X 1.0 in REG BEVEL hypodermic needles, packaged 100 per box, 50 boxes per case, with 5,000 units per case.

A total of 54,204,100 units are subject to this recall. The products 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. The recall includes specific catalog and lot numbers, with lot numbers ranging from 12-6780-x to 17-1791-x, where 'x' represents any release number.

These needles are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Because the documentation supporting sterility is insufficient, there is a potential risk that the products may not be sterile as claimed. Healthcare providers and facilities should stop using the affected needles and contact the manufacturer for further instructions.

The recalled product

Product: Hypodermic Needle, 21 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.
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 →

Moderate
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 · sterility