ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.
FDA Recall Z-0611-2009 · Posted 2009-01-13
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-11-07
Date Terminated2009-08-05
Product Quantity284 units
Reason for Recall
Biliary drainage catheter tips may separate from the catheter shaft after placement.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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