Reported Mar 23, 2022 · Ongoing
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
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?
- Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM
- Material NumberM00584060
- Lot codes and dates
- Lot Numbers
274633262746873027553568275909282762994127684747277642312779474427837500279317632798655028058938
- GTIN8714729778288
- Lot Numbers
- Amount recalled
- 1811 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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