Reported Feb 27, 2013 · Terminated
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 West Merit Parkway · South Jordan, UT · 84095
Is this the product you have?
- Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
- Lot codes and dates
Lot numbers H399931S1H411376H399938S1H411373H399940S1H411374H399942S1H411375H399948S1H411380H399950S1H411377H39952S1H411378H39953S1H411379
- Amount recalled
- 387 units
Where it was sold
Why it was recalled
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
This product could cause temporary or reversible health problems — stop using it.
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