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U.S. Department of Health and Human Services

Class 2 Device Recall Retrograde Cardioplegia Cannula, Manual inflating

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 Class 2 Device Recall Retrograde Cardioplegia Cannula, Manual inflatingsee related information
Date Initiated by FirmJuly 18, 2018
Create DateOctober 04, 2018
Recall Status1 Terminated 3 on April 04, 2019
Recall NumberZ-0068-2019
Recall Event ID 81042
510(K)NumberK964199 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductRetrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Code Information Lot code: 00794-030718
FEI Number 3004986960
Recalling Firm/
Manufacturer		 Surge Medical Sales, LLC (DBA Surge Cardiovascular)
2680 Walker Ave Nw
Grand Rapids MI 49544-1385
For Additional Information ContactMr. Robert Taylor
888-307-1146
Manufacturer Reason
for Recall		The device was built with the rigid insertion stylet instead of the flexible stylet.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm, MediSurge, contacted its customer via email on 7/18/18. The email described the product, problem and actions to be taken. If you have any questions, contact Director of Quality Assurance/Regulatory Affairs, at 616-202-6120 or email: kjonas@allianthealthcare.com.
Quantity in Commerce35 units
DistributionUS Distribution to state of: SC.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWF
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