Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
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 only a functional defect (resistance during advancement) with no reported illnesses, injuries, or deaths, making this a precautionary recall without documented adverse health consequences.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (REF: K12-09098B, Sterile EO, Rx ONLY) due to a reported issue with the catheter experiencing resistance when being advanced over the guidewire.
The recalled product was distributed nationwide in Colorado. The affected lot number is K12-09098B (UDI: 00884450771310).
Patients or healthcare providers who have received or are using this product should stop use and contact Merit Medical Systems, Inc. for further instructions. Healthcare providers should review patient records to identify any individuals who may have received this product.
The recalled product
- Product
- Philips Bridge Prep Kit REF: K12-09098B 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: 00884450771310
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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