Date Initiated by Firm | October 20, 2021 |
Create Date | November 04, 2021 |
Recall Status1 |
Terminated 3 on May 15, 2024 |
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 |
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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. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FMF
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