Date Initiated by Firm |
September 02, 2005 |
Date Posted |
October 21, 2005 |
Recall Status1 |
Terminated 3 on October 28, 2005 |
Recall Number |
Z-0079-06 |
Recall Event ID |
33364 |
510(K)Number |
K913682
|
Product Classification |
Catheter, Intravascular, Diagnostic - Product Code DQO
|
Product |
Merit Custom Procedure Kit |
Code Information |
Part Number: K09-05248P. Lot Numbers: A304826, A314447, A316544, A322290, A325742, A336903, A345355. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc 1600 West Merit Pkwy South Jordan UT 84095-2416
|
For Additional Information Contact |
801-253-1600
|
Manufacturer Reason for Recall |
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on 9/2/2005. |
Quantity in Commerce |
243 units |
Distribution |
DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts. |
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.
|
510(K) Database |
510(K)s with Product Code = DQO and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
|