Recall Z-0202-2022 ยท FMF Syringe, Piston
MICROVENTION INC.
Aspiration Syringe Kit, REF: MVSK60
| Date | Oct 20, 2021 |
| Status | Terminated |
| Reason | Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 33 |
| Distribution | US Nationwide distribution in the states of AL, NY, NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994253 | VACLOK SYRINGE Merit Medical Systems, Inc., Jan 5, 2000 |