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Recall Observatory FDA recall evidence

Device product

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

Z-2352-2015

June 29, 2015

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 71694
Status
Terminated
Classification
Class II
Quantity
950
Official record key
device-enforcement:Z-2352-2015

Official wording

Reason: 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.

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

Distribution pattern: Nationwide Distribution including the Virgin Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.