DREAMTOME medical device recall: sterility compromised by barrier breach
Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for sterile barrier compromise with no reported illnesses or injuries. The hazard represents a risk-of-harm scenario where injury has not yet been reported, meeting the High severity rubric criterion.
Plain-English summary
Boston Scientific Corporation is recalling 15 units of the DREAMTOME 49-20MM/450CM medical device (Material Number: M00584020) due to a sterile barrier breach.
The sterile barrier of the affected devices is compromised, which means the device sterility cannot be assured. The lot number affected is 27802363.
These devices were distributed worldwide, including in the United States and internationally to countries including Australia, Austria, Belgium, Canada, China, 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 Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Arab Emirates.
Individuals who may have access to these devices should contact Boston Scientific Corporation for guidance. The company has initiated this recall to address the sterility concern.
The recalled product
- Product
- DREAMTOME 49-20MM/450CM Material Number: M00584020
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- sterile-barrier-breach
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 27802363 GTIN: 8714729778240
Distribution
Distributed nationwide across the United States.
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