HIGHFDA DEVICE

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

catheter may experience resistance when being advanced over the guidewire

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 2, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 2, 2026
Hazard Level
HIGH
Brand
Merit Medical Systems
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Merit Medical Systems
Model numbers
All Lot Numbers/UDI: 00884450771310
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 2, 2026

  2. Reported by FDA DEVICE

    May 6, 2026

  3. RecallRadar source check

    May 13, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

catheter may experience resistance when being advanced over the guidewire

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY. Reason: catheter may experience resistance when being advanced over the guidewire. Classification: Class II. Distribution: US Nationwide distribution in the state of CO.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
All Lot Numbers/UDI: 00884450771310
Affected States
ALL
Report Date
May 6, 2026
Recall Status
ACTIVE

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