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Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

FDA Recall #Z-1085-2024 — Class II — December 6, 2023

Recall #Z-1085-2024 Date: December 6, 2023 Classification: Class II Status: Ongoing

Product Description

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Reason for Recall

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Recalling Firm

Stryker, Inc. — Salt Lake City, UT

Classification

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

Product Type

Devices

Product Quantity

63 units

Distribution

US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.

Code Information

UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674

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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