Device Recall ReSolve Locking Drainage Catheters 의 리콜

Recall

71694

Class 2

Z-2352-2015

2015-06-29

2015-08-07

Terminated

United States

2015-10-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138760

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.

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.