Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II. The source text describes a functional defect (resistance during advancement) rather than a high-risk pathogen or allergen hazard, and no illnesses or serious injuries are reported, warranting a Moderate severity score.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (REF: K12-09098C, Sterile EO, Rx Only) distributed nationwide. The catheter component may experience resistance when being advanced over the guidewire, which could compromise the proper function of the device during use.
The product was distributed in the United States, including Colorado. Patients and healthcare providers who have this device should contact their physician or Merit Medical Systems for instructions on device replacement or management.
The recalled product
- Product
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Catheter Kit
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 (1)
- All Lot Numbers/UDI: 00884450816509
Distribution
Part of a larger recall action
This product is one of 3 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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