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Recall Observatory FDA recall evidence

Device product

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Z-2662-2018

April 13, 2018

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 80490
Status
Terminated
Classification
Class II
Quantity
276 units
Official record key
device-enforcement:Z-2662-2018

Official wording

Reason: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

Code information: Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421

Distribution pattern: US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.