Dreamtome Cannulating Sphincterotome-DREAMTOME recall: Sterility Concern
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Why was Dreamtome Cannulating Sphincterotome-DREAMTOME recalled?
Sterility of device is compromised due to a sterile barrier breach
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 27463326 27468730 27553568 27590928 27629941 27684747 27764231 27794744 27837500 27931763 27986550 28058938 GTIN: 8714729778288
- Product
- Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1811 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
- Recall date
- March 23, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)