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Recall Observatory FDA recall evidence

Device product

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Z-1543-2024

December 19, 2023

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 93771
Status
Ongoing
Classification
Class II
Quantity
1842 guide barrel clamps
Official record key
device-enforcement:Z-1543-2024

Official wording

Reason: 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.

Code information: Lot Numbers: P0407365, P0486670, P0561740

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.