FDAFDA · Food and drugs·Recall number Z-1085-2024
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Published February 21, 2024 · Recall initiated: December 6, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker, Inc.
- Distributor
- US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
- Lot
- UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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