Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc.,
FDA device recall Z-0852-2011 · posted 2011-01-05 · Terminated
Recall details
- Recalling firm
- Vance Products Incorporated
- Reason for recall
- The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.
- Action taken
- The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FAD
- Quantity affected
- 25 units
- Distribution
- Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada.
- Date initiated
- 2010-10-18
- Date posted
- 2011-01-05
- Date terminated
- 2011-07-27
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQ HYDROPHILIC STENT (K961446) | Cook Urological, Inc. | 1996-05-28 |