Moderate FDA (Devices)·Z-2860-2017·Announced 2017-08-16

FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

International Medsurg Connection, Inc. is recalling 30 CC L/S Piston Syringes because the company lacks sufficient documentation to support the product's 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, but the specific hazard is a documentation deficiency regarding sterility claims rather than a confirmed contamination or reported injury, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate severity.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Piston Syringes, 30 CC L/S, manufactured by International Medsurg Connection, Inc. The recall was initiated because the firm has insufficient documentation to support the product's sterility claims. These syringes are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The recall affects 54,204,100 units of the product, identified by Catalog No. SY35030LS. The distribution was nationwide, including states such as 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 Z-2860-2017.

Healthcare facilities and distributors should stop using the affected syringes and contact the recalling firm for instructions on return or disposal. Consumers who have purchased these products should contact their healthcare provider or the manufacturer for further guidance.

The recalled product

Product: Piston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/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 prevention of disease
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Syringes
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