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Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

FDA Recall #Z-1543-2024 — Class II — December 19, 2023

Recall #Z-1543-2024 Date: December 19, 2023 Classification: Class II Status: Ongoing

Product Description

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Reason for Recall

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.

Recalling Firm

Smiths Medical ASD Inc. — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1842 guide barrel clamps

Distribution

Worldwide distribution.

Code Information

Lot Numbers: P0407365, P0486670, P0561740

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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