Moderate FDA (Devices)·Z-2825-2017·Announced 2017-08-16

FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide 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 due to insufficient documentation supporting sterility claims, which is a documentation issue rather than a confirmed contamination or injury event, fitting the Moderate severity criteria for low-risk or precautionary recalls.

Plain-English summary

International Medsurg Connection, Inc. is recalling 54,204,100 units of Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8. The products are used to inject fluids into, or withdraw fluids from, the body for the diagnosis, cure, mitigation, treatment, or prevention of disease. The recall was initiated because the company has insufficient documentation to support the product sterility claims.

The affected 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 covers specific catalog and lot numbers, with lot numbers ranging from 12-6780-x to 17-1791-x, where 'x' represents any release number.

Healthcare facilities and consumers should stop using the affected syringes and needles and contact International Medsurg Connection, Inc. for further instructions or a return. The FDA has classified 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: Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case, 3,000/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,
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Syringes and 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 documentation