Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating see related information
Date Initiated by Firm November 10, 2008
Date Posted February 10, 2009
Recall Status1 Terminated 3 on November 25, 2009
Recall Number Z-0980-2009
Recall Event ID 50223
510(K)Number K961446  
Product Classification Stent, ureteral - Product Code FAD
Product Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box.

The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.
Code Information Lot Number: U1753668.
Recalling Firm/
Manufacturer		 Vance Products Incorporated
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information Contact
812-829-4891
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action 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.
Quantity in Commerce 23
Distribution Nationwide Distribution including states of Georgia, Oregon and Texas.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FAD and Original Applicant = COOK UROLOGICAL, INC.
-
-