Merit Medical Systems Recalls Biliary Locking Drainage Catheters Due to Breakage
Merit Medical Systems is recalling 387 Resolve Biliary Locking Drainage Catheters because a consumer reported the device broke into several pieces during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural failure of a medical device (catheter breakage) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merit Medical Systems, Inc. is recalling 387 units of the Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC. These medical devices are used for the drainage of bile within the biliary system. The recall was initiated after a consumer complaint reported that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
The affected units were distributed worldwide, including in the United States (specifically New Jersey, Florida, Georgia, Missouri, Arizona, and Utah) and Denmark. The specific lot numbers involved in this recall are H399931S1, H411376, H399938S1, H411373, H399940S1, H411374, H411375, H399948S1, H411380, H399950S1, H411377, H39952S1, H411378, H39953S1, and H411379.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the device is currently in use or has been used, providers should contact Merit Medical Systems for further instructions on how to proceed.
The recalled product
- Product
- Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 387
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lot numbers H399931S1
- H411376
- H399938S1
- H411373
- H399940S1
- H411374
- H399942S1
- H411375
- H399948S1
- H411380
- H399950S1
- H411377
- H39952S1
- H411378
- H39953S1
- H411379.
Distribution
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