Date Initiated by Firm |
June 29, 2015 |
Date Posted |
August 07, 2015 |
Recall Status1 |
Terminated 3 on October 26, 2015 |
Recall Number |
Z-2352-2015 |
Recall Event ID |
71694 |
Product Classification |
Catheter, continuous irrigation - Product Code GBQ
|
Product |
ReSolve Locking Drainage Catheters
The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities. |
Code Information |
Lot No: E796578 E796579 MR792035 MR786325 MR797946 MR791206 MR791212 MR786923 E796605 MR786311 MR791660 E796647 RL MR795466 MR786301 E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318 MR786319 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan UT 84095
|
For Additional Information Contact |
Luke Meidell 801-208-4623
|
Manufacturer Reason for Recall |
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the
package.
|
FDA Determined Cause 2 |
Employee error |
Action |
Merit Medical Systems sent an Urgent Product Recall Notice dated July 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions required of you:
1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. Due to the nature of this label discrepancy, you will need to physically verify whether product in inventory is within the scope of this recall. Your Merit Sales Representative can assist you with this determination.
2. Ensure that all personnel to whom the devices were distributed are made aware of this field action.
3. Please work with your Merit Sales Representative to arrange product return.
4. If you have any questions concerning this communication, please don't hesitate to contact your Merit Sales Representative or call (801)208-4365. |
Quantity in Commerce |
950 |
Distribution |
Nationwide Distribution including the Virgin Islands. |
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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