DREAMTOME 49-20MM/450CM Material Number: M00584020 recall: Sterility Concern
DREAMTOME 49-20MM/450CM Material Number: M00584020
Why was DREAMTOME 49-20MM/450CM Material Number: M00584020 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: 27802363 GTIN: 8714729778240
- Product
- DREAMTOME 49-20MM/450CM Material Number: M00584020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 15 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)