Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
- Company
- Boston Scientific
- Recall Initiated
- March 9, 2020
- Posted
- April 1, 2020
- Recall Number
- Z-1738-2020
- Quantity
- 50 units
- Firm Location
- Marlborough, MA
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
Distribution
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Lot / Code Info
Lot Numbers: 24724232
Root Cause
Component change control
Action Taken
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.