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U.S. Department of Health and Human Services

Class 2 Device Recall ReSolve Locking Drainage Catheters

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  Class 2 Device Recall ReSolve Locking Drainage Catheters see related information
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
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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