Reported Mar 23, 2022 · Ongoing

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400…

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234

Is this the product you have?

  • RX CHOLANGIOGRAM
  • KIT - SINGLE Material Number
    • M00575240
    • M00575240
    • M00575280
    • M00575320
    • M00575360
    • M00575380
    • M00575400
    • M00575440
    • M00575480
Lot codes and dates
  • Lot Numbers/UDI
    • 27877022
    • 8714729750031
    • 28098229
    • 8714729750031
    • 28329450
    • 8714729750031
    • 27803952
    • 8714729750079
    • 27877021
    • 8714729750079
    • 27914711
    • 8714729750079
    • 27950226
    • 8714729750079
    • 28110693
    • 8714729750079
    • 27950225
    • 8714729750116
    • 28018192
    • 8714729750116
    • 28253295
    • 8714729750116
    • 28069582
    • 8714729750154
    • 27751896
    • 8714729750178
    • 27983611
    • 8714729750178
    • 28296770
    • 8714729750192
    • 27658435
    • 8714729750239
    • 27891175
    • 8714729750239
    • 28018195
    • 8714729750239
    • 27914712
    • 8714729750277
Amount recalled
N/A

This recall covers 31 products

The agency filed one notice per product. You are reading one of them; the other 30 are below.

18 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Sterility of device is compromised due to a sterile barrier breach

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.