| Date Initiated by Firm | October 20, 2021 |
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| Create Date | November 04, 2021 |
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| Recall Status1 |
Terminated 3 on May 15, 2024 |
| Recall Number | Z-0202-2022 |
|---|
| Recall Event ID |
88892 |
| 510(K)Number | K994253 |
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| 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 |
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| Distribution | US Nationwide distribution in the states of AL, NY, NV. |
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| 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.
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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