Z-2352-2015Class II

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of...

Name: Z-2352-2015 ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of...
Creator: Merit Medical Systems, Inc.
Published: 2015-06-29
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2015-06-29 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities on 2015-06-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2352-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Posted: 2015-08-07
Terminated: 2015-10-26
Recalling firm: Merit Medical Systems, Inc.
Product: ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Product code: GBQ Catheter, Continuous Irrigation
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2352-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2352-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-07

Product code GBQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)