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U.S. Department of Health and Human Services

Class 2 Device Recall Universa Soft Ureteral Stent

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  Class 2 Device Recall Universa Soft Ureteral Stent see related information
Date Initiated by Firm October 18, 2010
Date Posted January 05, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-0852-2011
Recall Event ID 57352
510(K)Number K961446  
Product Classification Ureteral Stent - Product Code FAD
Product Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN.

Used for temporary internal drainage from the ureteropelvic junction to the bladder.
Code Information Lot number: U1987598.
Recalling Firm/
Vance Products Incorporated
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information Contact Julie Cooper
Manufacturer 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.
FDA Determined
Cause 2
Action 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.
Quantity in Commerce 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.
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.