ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
FDA Recall Z-2352-2015 · Posted 2015-08-07
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeGBQ
Date Initiated2015-06-29
Date Terminated2015-10-26
Product Quantity950
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution including the Virgin Islands.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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