Aspiration Syringe Kit, REF: MVSK60 recallZ-0202-2022 · Microvention Inc. · initiated Oct 20, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microvention Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
FDA root cause category: Under Investigation by firm
What the company is doing
On 10/20/21, recall notices were sent to customers. Customers were asked to identify and quarantine all impacted kits. Complete and return the response form. Return affected devices to the manufacturer including a copy of the completed response form. The following contact information was provided to customers with additional questions: [email protected], and 714-247-8143 or 949-501-0355, Hours: Monday -Friday PST 8:00-5:00 pm.
Recall details
- Recall number
- Z-0202-2022
- Status
- Terminated
- Initiated by the company
- Oct 20, 2021
- Recalling firm
- Microvention Inc.
- Quantity
- 33
- Product code
- FMF
- FDA submissions
- K994253
- Distribution
- US Nationwide distribution in the states of AL, NY, NV.
Product description
Aspiration Syringe Kit, REF: MVSK60
Code information (models, lots, serial numbers)
Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Syringe Kit - Stroke MVSK60Microvention, Inc. · Syringe, piston1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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