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.
What this means for you
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
- Hazard
- device-malfunction
- resistance-during-use
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
Distributed nationwide across the United States.
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