DREAMTOME 49-30MM/450CM Material Number: M00584030
Reported: March 23, 2022 Initiated: December 22, 2021 #Z-0758-2022
Product Description
DREAMTOME 49-30MM/450CM Material Number: M00584030
Reason for Recall
Sterility of device is compromised due to a sterile barrier breach
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 32 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.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
DREAMTOME 49-30MM/450CM Material Number: M00584030. Recalled by Boston Scientific Corporation. Units affected: 32 units.
Why was this product recalled? ▼
Sterility of device is compromised due to a sterile barrier breach
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Moderate. Recall number: Z-0758-2022.
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