Moderate FDA (Devices)·Z-2839-2017·Announced 2017-08-16

FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles nationwide because the company lacks sufficient documentation to support product 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 hazard is a documentation deficiency regarding sterility claims rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for piston syringes and hypodermic needles (5 CC L/L 20 G X 1.5) manufactured by International Medsurg Connection, Inc. The recall involves 54,204,100 units of the product, which is 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 manufacturer has insufficient documentation to support the product's 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.

Healthcare providers and consumers should check their inventory for the specific catalog number SN0052015 and the listed lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA advises that users contact their healthcare provider if they have concerns about the sterility of the devices used.

The recalled product

Product: Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/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