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Recall Observatory FDA recall evidence

Device product

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01

Z-2002-2020

January 02, 2020

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 85361
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-2002-2020

Official wording

Reason: Inability for the guidewire to pass through the needles included with the catheter kits.

Code information: LOT Number/ UDI - 4350491/0 0840619 03011 7

Distribution pattern: US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inability for the guidewire to pass through the needles included with the catheter kits.