Z-0613-2009

ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems...

Name: Z-0613-2009 ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems...
Creator: Merit Medical Systems, Inc.
Published: 2008-11-07
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-11-07 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage... on 2008-11-07. The reason FDA records is "Biliary drainage catheter tips may separate from the catheter shaft after placement". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0613-2009
Status: Terminated
Initiated: 2008-11-07
Posted: 2009-01-13
Terminated: 2009-08-05
Recalling firm: Merit Medical Systems, Inc.
Product: ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Biliary drainage catheter tips may separate from the catheter shaft after placement.
FDA root cause: Other
Action: Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929.
Quantity in commerce: 244 units
Distribution: Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.
Product codes and lots: Lot numbers: G543417, MR604365, and MR607896.

Product code FGE

K063733Class IIResolve Biliary Drainage CatheterMerit Medical Systems, Inc. / cleared 2007-11-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)