Class 2 Device Recall Surge Medical Solutions Retrograde Cardioplegia Cannula

• Date Initiated by Firm: April 17, 2007
• Date Posted: June 06, 2007
• Recall Status: Terminated on March 10, 2009
• Recall Number: Z-0892-2007
• Recall Event ID: 37806
• 510(K)Number: K964393
• Product Classification: Cannula, cardioplegia - Product Code DWF
• Product: Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-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 MI 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: Other
• 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 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 = DWF