Reported Mar 23, 2022 · Ongoing

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481

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 Material Numbers
    • M00575241
    • M00575281
    • M00575321
    • M00575361
    • M00575381
    • M00575401
    • M00575441
    • M00575481
Lot codes and dates

7 of 7 products

Products covered by this recall
#BarcodesProduct as published
18714729818380M00575241 RX CHOLANGIOGRAM KIT: Lot Numbers"27879206, 28103331, 28336117 UDI: 8714729818380
287147298184108714729818427M00575281 RX CHOLANGIOGRAM KIT Lot Numbers: 27803953, 27878151, 27919775 UDI: 8714729818410 M00575321 RX CHOLANGIOGRAM KIT Lot Numbers: 27955111, 28024443, 28269925 UDI: 8714729818427
38714729818458M00575361 RX CHOLANGIOGRAM KIT Lot Number:28074763 UDI:8714729818458
48714729818465M00575381 RX CHOLANGIOGRAM KIT Lot Numbers: 27755939, 27990502 UDI: 8714729818465
58714729818472M00575401 RX CHOLANGIOGRAM KIT Lot NUmber: 28311945 UDI:8714729818472
68714729818489M00575441 RX CHOLANGIOGRAM KIT Lot Numbers: 27673853, 27891176 , 28024444 UDI: 8714729818489
78714729818496M00575481 RX CHOLANGIOGRAM KIT Lot Numbers: 27919776, 28060354 UDI: 8714729818496.
Amount recalled
500 units

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, 5:33 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.