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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-0901-2007
Recall Event ID 37806
Premarket Notification
510(K) Number
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 20 mm, rigid insertion stylet, sterile, REF CODE: RSR-L014S.
Code Information All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
Recalling Firm/
Surge Medical Solutions, LLC
3710 Sysco Court S.E.
Grand Rapids, Michigan 49512
For Additional Information Contact Ray Lokers
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
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.