Boston Scientific Corporation Recall 89468
Description: DREAMTOME 49-30MM/260CM Material Number: M00584010
Boston Scientific Corporation Recall 89468 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0757-2022 |
| Event ID | 89468 |
| Event Description | DREAMTOME 49-30MM/260CM Material Number: M00584010 |
| Product Type | Devices |
| 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. |
| Quantity | 472 units |
| Recall Reason | Sterility of device is compromised due to a sterile barrier breach |
| Device Classification | 20220323 |
| Device Code Info | Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233 |
| Center Classification Date | 20220311 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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