DREAMTOME 44-30MM/260CM Material Number: M00584050 recall: Sterility Concern
DREAMTOME 44-30MM/260CM Material Number: M00584050
Why was DREAMTOME 44-30MM/260CM Material Number: M00584050 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: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271
- Product
- DREAMTOME 44-30MM/260CM Material Number: M00584050
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 12067 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)