Aspiration Syringe Kit, REF: MVSK60
FDA Recall Z-0202-2022 · Posted None
Recalling FirmMICROVENTION INC.
Recall StatusTerminated
Product CodeFMF
Date Initiated2021-10-20
Date Terminated2024-05-15
Product Quantity33
Reason for Recall
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
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: [email protected], and 714-247-8143 or 949-501-0355, Hours: Monday -Friday PST 8:00-5:00 pm.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of AL, NY, NV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.