Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
FDA Recall Z-0866-2013 · Posted 2013-02-20
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2013-01-16
Date Terminated2015-09-16
Product Quantity387 units
Reason for Recall
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Firm Action
Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product.
Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused product if applicable.
All product on hand at Merit was inventoried and remains under quarantined status.
Further questions please call (801) 208-4301,
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
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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