Recall Z-0505-2018
Cardiovascular Systems Inc · initiated September 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145
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: Labeling mix-ups
Action taken
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
Details
- Recall number
- Z-0505-2018
- Initiated
- September 14, 2017
- Terminated
- November 4, 2019
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 8
- Distribution
- FL, IL, MI, MN, MO, NY, SC, TX, and WI
- Recalling firm
- Cardiovascular Systems Inc, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0506-2018 Class II | Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system…Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for… | 09/14/2017Terminated |