Z-2971-2020 Class II Terminated
FDA device recall Z-2971-2020 was initiated by Cook Inc. on July 30, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 4, 2021). Affected quantity: 20 units.
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