Merit Medical Systems Inc recall
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Why was Merit Medical Systems Inc recalled?
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
- Product
- Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 387 units
- Distribution
- Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
- Recall date
- February 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)