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U.S. Department of Health and Human Services

Class 2 Device Recall Syringe Kit

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  Class 2 Device Recall Syringe Kit see related information
Date Initiated by Firm October 20, 2021
Create Date November 04, 2021
Recall Status1 Completed
Recall Number Z-0202-2022
Recall Event ID 88892
510(K)Number K994253  
Product Classification Syringe, piston - Product Code FMF
Product Aspiration Syringe Kit, REF: MVSK60
Code Information Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information Contact
714-247-8159
Manufacturer Reason
for Recall		 Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
FDA Determined
Cause 2		 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 in Commerce 33
Distribution US Nationwide distribution in the states of AL, NY, NV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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