Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological
FDA device recall Z-0980-2009 · posted 2009-02-10 · Terminated
Recall details
- Recalling firm
- Vance Products Incorporated
- Reason for recall
- "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.
- Action taken
- Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FAD
- Quantity affected
- 23
- Distribution
- Nationwide Distribution including states of Georgia, Oregon and Texas.
- Date initiated
- 2008-11-10
- Date posted
- 2009-02-10
- Date terminated
- 2009-11-25
- 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 |