|
Class 2 Device Recall Polaris Ultra Ureteral Stent Set |
|
Date Initiated by Firm |
March 09, 2020 |
Date Posted |
April 01, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1740-2020 |
Recall Event ID |
85227 |
Product Classification |
Stylet for catheter, gastro-urology - Product Code EZB
|
Product |
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 |
Code Information |
Lot Numbers: 24749818, 24913418 |
Recalling Firm/ Manufacturer |
Boston Scientific 100 Boston Scientific Way Marlborough MA 01752-1234
|
For Additional Information Contact |
Nicole Pshon 763-494-1133
|
Manufacturer Reason for Recall |
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a
procedural delay due to the need to exchange the affected device
|
FDA Determined Cause 2 |
Component change control |
Action |
Boston Scientific issued Customer Notification on March 9, 2020 stating reason for recall, health risk and action to take: cease distribution or use of any remaining product affected by this removal should cease immediately; Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Verification Form the quantity of units from each lot/batch that you will bereturning. As some of these products within these lots/batches are sold as 5-packs, it is important that all
reported quantities represent the actual number of single units being returned and not the number of cartons/boxes or multi-packs; If you identify any product from the affected lots/batches within your inventory, please segregate the
product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth is to the hospital level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital within your network, please ensure that this notification is forwarded to them. |
Quantity in Commerce |
19 units |
Distribution |
Nationwide
Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|