Moderate FDA (Devices)·Z-2804-2017·Announced 2017-08-16

FDA Recalls Syringe Bulbs Due to Insufficient Sterility Documentation

International Medsurg Connection, Inc. is recalling 60 CC Syringe Bulbs 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, and the hazard is a documentation deficiency regarding sterility claims rather than a confirmed contamination event or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

International Medsurg Connection, Inc. is recalling 60 CC Syringe Bulbs (Catalog No. 46227) because the company has insufficient documentation to support the product's sterility claims. The products are used to inject fluids into, or withdraw fluids from, the body and are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

The recall involves 54,204,100 units 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 numerous specific lot numbers, which are listed in the official FDA recall notice Z-2804-2017.

Healthcare facilities and distributors should stop using the affected syringe bulbs and contact the recalling firm for instructions on return or disposal. Consumers should not use these products and should contact their healthcare provider if they have questions about the recall.

The recalled product

Product: Syringe Bulb, 60 CC 50 pcs per 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, or to affect the struct
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Syringe Bulbs
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)

Catalog No. 46227. Known Lot No. ("x" represents any release number): 12-6780-x
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

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
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Same hazard · sterility documentation