Recall Z-2971-2020— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2020-07-30, terminated 2021-11-04. It names 2 FDA 510(k) clearances: K161236, K151051. Product: 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: 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-30
- Terminated
- 2021-11-04
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K161236 — Universa Firm Ureteral Stents and Stent Sets
- K151051 — Universa Soft Ureteral Stents and Stent Sets
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.