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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Salle Intraoperative Pyeloplasty Stent Set

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  Class 2 Device Recall Cook Salle Intraoperative Pyeloplasty Stent Set see related information
Date Initiated by Firm April 22, 2019
Create Date May 17, 2019
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-1370-2019
Recall Event ID 82795
510(K)Number K810368  
Product Classification Catheter, suprapubic (and accessories) - Product Code KOB
Product Cook Salle Intraoperative Pyeloplasty Stent Set
PRODUCT/CATALOG NUMBER/GPN:
4.0 Fr - SIPSF-040018-56-6 G18168
4.0 Fr - SIPSF-040018-59 G32773
4.7 Fr SIPSF-050018-59 G32774
Code Information All lot codes
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Dept
812-339-2235
Manufacturer Reason
for Recall		 Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
FDA Determined
Cause 2		 Error in labeling
Action Cook issued MEDICAL DEVICE CORRECTION letters via courier to US Consignees on April 22, 2019. The letter provides reason for recall, products affected, health risk, action to take: Understand that stent knotting is a potential complication associated with use of the Kwart Retro-Inject" Stent Set and Salle Intraoperative Pyeloplasty Stent Set and should be considered if significant resistance is encountered during attempts at removal. 2. Please maintain a copy of this notice with the current IFU or product(s) in your inventory. 3. If you have affected product in inventory, you may continue to use these products. Cook Medical is not requesting product be returned. 4. Complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter.5. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred. Questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Quantity in Commerce 3711
Distribution Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jordan Slovakia South Africa United Arab Emirates Slovenia Lithuania Morocco Romania Qatar Bulgaria Libya Saudi Arabia Turkey Ukraine Thailand
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 = KOB and Original Applicant = VANCE PRODUCTS, INC.
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