Date Initiated by Firm |
July 18, 2018 |
Create Date |
October 04, 2018 |
Recall Status1 |
Terminated 3 on April 04, 2019 |
Recall Number |
Z-0068-2019 |
Recall Event ID |
81042 |
510(K)Number |
K964199
|
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
Product |
Retrograde 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 |
Recalling Firm/ Manufacturer |
Surge Medical Sales, LLC (DBA Surge Cardiovascular) 2680 Walker Ave Nw Grand Rapids MI 49544-1385
|
For Additional Information Contact |
Mr. 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 |
Action |
The 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 Commerce |
35 units |
Distribution |
US Distribution to state of: SC. |
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 and Original Applicant = CHASE MEDICAL, INC.
|