Device recall

Z-0866-2013: Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models…

FDA device recall · Class II · Merit Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-0866-2013
Recall event 64202
Product Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Product code FGE
Recalling firm Merit Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Sep 16, 2015
510(k) numbers K121832
FEI number 1721504

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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