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U.S. Department of Health and Human Services

Class 2 Device Recall Surge Medical Solutions Retrograde Cardioplegia Cannula

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 Class 2 Recall
Surge Medical Solutions Retrograde Cardioplegia Cannula
see related information
Date Posted June 06, 2007
Recall Status1 Terminated on March 10, 2009
Recall Number Z-0896-2007
Recall Event ID 37806
Premarket Notification
510(K) Number
K964393 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S.
Code Information All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
Recalling Firm/
Manufacturer
Surge Medical Solutions, LLC
3710 Sysco Court S.E.
Grand Rapids, Michigan 49512
For Additional Information Contact Ray Lokers
800-950-9860
Manufacturer Reason
for Recall
The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
Quantity in Commerce 2,211 for all Recalls Z-0892-0904-2007
Distribution Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = CHASE MEDICAL, INC.
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