Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire 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 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 a Class II recall. The source text describes a potential functional defect (resistance during catheter advancement) with no reported illnesses or injuries, making this a precautionary recall that does not meet the threshold for High severity.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C, Lot/UDI 00884450024140) distributed nationwide in Colorado. The catheter component may experience resistance when being advanced over the guidewire, which could affect proper device function during clinical use.
This is an FDA Class II recall. Patients or healthcare providers who have this product should contact Merit Medical Systems, Inc. for instructions on product return or replacement. Consult with your healthcare provider if you have questions about whether you have received this product or about your treatment.
The recalled product
- Product
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Manufacturer
- Merit Medical Systems, Inc.
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: 00884450024140
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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