Date Initiated by Firm | September 14, 2017 |
Create Date | October 11, 2018 |
Recall Status1 |
Terminated 3 on November 04, 2019 |
Recall Number | Z-0505-2018 |
Recall Event ID |
78897 |
510(K)Number | K152694 |
Product Classification |
Catheter, peripheral, atherectomy - Product Code MCW
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Product | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. |
Code Information |
Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145 |
Recalling Firm/ Manufacturer |
Cardiovascular Systems Inc 1225 Old Highway 8 NW Saint Paul MN 55112-6416
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For Additional Information Contact | Field Action Hotline 651-259-2800 |
Manufacturer Reason for Recall | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | On 09/14/2017 the firm sent letters to their consignees explaining the recall and given the following instructions:
Please immediately remove from use and return the affected Product Name devices to CSI. To do so:
1) Complete the attached Customer Acknowledgement Form
a. Per lot, document the quantity of all devices that are to be returned.
b. Per lot, document the quantity of all devices that have been consumed.
2) Place the Acknowledgement Form with the device
3) Return the device and Acknowledgement Form to CSI using the pre-paid FedEx label
a. If you would like, a CSI Sales Representative can return the device and form. Please contact the CSI Recall Coordinator to organize pick up and return of the product. If all products specified in this recall notice have previously been consumed, used or are no longer available for return to CSI, please complete the Customer Acknowledgment Form per the above, and return the form to CSI in the provided FedEx envelope.
Contact Information: csifieldactionhotline@csi360.com
651-259-2800 - Tel |
Quantity in Commerce | 8 |
Distribution | FL, IL, MI, MN, MO, NY, SC, TX, and WI |
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 = MCW
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