FDAClass IIApril 24, 2024

Smiths Medical Medfusion Guide Barrel Clamp recall

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Why was Smiths Medical Medfusion Guide Barrel Clamp recalled?

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: P0407365, P0486670, P0561740

Product
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Recalling firm
Smiths Medical ASD Inc.
Quantity
1842 guide barrel clamps
Distribution
Worldwide distribution.
Recall date
April 24, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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