Aspiration Syringe Kit, REF: MVSK60
This recall has been terminated (originally issued October 20, 2021).
- Company
- Microvention Inc.
- Recall Initiated
- October 20, 2021
- Terminated
- May 15, 2024
- Recall Number
- Z-0202-2022
- Quantity
- 33
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Distribution
US Nationwide distribution in the states of AL, NY, NV.
Lot / Code Info
Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
Root Cause
Under Investigation by firm
Action Taken
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: FieldAssurance@microvention.com, and 714-247-8143 or 949-501-0355, Hours: Monday -Friday PST 8:00-5:00 pm.