Z-2971-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- July 30, 2020
- Termination Date
- November 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
Reason for Recall
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Distribution Pattern
International distribution to the country of Australia.
Code Information
Lot Number: 13060084