Z-1740-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 9, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
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 Pattern
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Code Information
Lot Numbers: 24749818, 24913418