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Class 2 Device Recall Surge Medical Solutions Retrograde Cardioplegia Cannula |
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Date Initiated by Firm |
April 17, 2007 |
Date Posted |
June 06, 2007 |
Recall Status1 |
Terminated 3 on March 10, 2009 |
Recall Number |
Z-0897-2007 |
Recall Event ID |
37806 |
510(K)Number |
K964393
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Product Classification |
Cannula, cardioplegia - Product Code DWF
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Product |
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L. |
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
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For Additional Information Contact |
Ray Lokers 800-950-9860
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = CHASE MEDICAL, INC.
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