CLASS II Device recall · Reported 27 Feb 2013 · FDA Enforcement Report
Resolve Biliary Locking Drainage Catheter recalled
Merit Medical Systems is recalling Resolve Biliary Locking Drainage Catheter, distributed in Arizona, Florida, Georgia, Missouri, New Jersey, Utah. The recall was initiated on 16 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0866-2013
- FDA event ID
- 64202
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2013
- FDA classified
- 20 Feb 2013
- Reported
- 27 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 16 Jan 2013 | Recall initiated by company | |
| 20 Feb 2013 | Classified by FDA | +35 days |
| 27 Feb 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Product as listed by the FDA
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Where it was distributed
Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
Questions about this recall
Why was it recalled?
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Which lots are affected?
Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
Where was it sold?
Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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