Stryker, Inc. Recall 93678
Description: Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Stryker, Inc. Recall 93678 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1084-2024 |
Event ID | 93678 |
Event Description | Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA. |
Quantity | 11 units |
Recall Reason | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
Device Classification | 20240221 |
Device Code Info | UDI: (01)00815742002386/Lot Number(s): 0000228865 0000370674 |
Center Classification Date | 20240214 |
Recall Initiation Date | 20231206 |
Recalling Firm | Stryker, Inc. |
Initial Notification | Letter |
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