Reported Mar 23, 2022 · Ongoing
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
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 RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM
- Material NumberM00584040
- Lot codes and dates
- Batch Numbers
27446479274483372747085727473288274790072748895527519099275832482758492027609359276102302761651727674795276791502768137227682823277106502771591527740170277429662774678327747640277707492777909027781488277842842780690627808089278139032781880527869283278729562795517827958586279652942802141328054973281180522829677728296779
- GTIN8714729778264
- Batch Numbers
- Amount recalled
- 21309 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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