ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from b

FDA device recall Z-2352-2015 · posted 2015-08-07 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

GBQ

Quantity affected

950

Distribution

Nationwide Distribution including the Virgin Islands.

Date initiated

2015-06-29

Date posted

2015-08-07

Date terminated

2015-10-26

Location

South Jordan, UT