FDAFDA · Food and drugs·Recall number Z-0866-2013
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Published February 27, 2013 · Recall initiated: January 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
- Lot
- Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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