Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Reported: February 27, 2013 Initiated: January 16, 2013 #Z-0866-2013
Product Description
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Reason for Recall
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 387 units
- Distribution
- Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.. Recalled by Merit Medical Systems, Inc.. Units affected: 387 units.
Why was this product recalled? ▼
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2013. Severity: Moderate. Recall number: Z-0866-2013.
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