Date Initiated by Firm |
January 16, 2013 |
Date Posted |
February 20, 2013 |
Recall Status1 |
Terminated 3 on September 16, 2015 |
Recall Number |
Z-0866-2013 |
Recall Event ID |
64202 |
510(K)Number |
K121832
|
Product Classification |
Catheter, biliary, diagnostic - Product Code FGE
|
Product |
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
|
Code Information |
Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan UT 84095
|
For Additional Information Contact |
Mr. Paul Kennedy 801-208-4301
|
Manufacturer Reason for Recall |
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product.
Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused product if applicable.
All product on hand at Merit was inventoried and remains under quarantined status.
Further questions please call (801) 208-4301, |
Quantity in Commerce |
387 units |
Distribution |
Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark |
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 = FGE and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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