Boston Scientific Corporation Recall 89468
Description: JAGTOME RX 39-30-260-025 Material Number: M00573100
Boston Scientific Corporation Recall 89468 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0770-2022 |
| Event ID | 89468 |
| Event Description | JAGTOME RX 39-30-260-025 Material Number: M00573100 |
| 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 | 1447 units |
| Recall Reason | Sterility of device is compromised due to a sterile barrier breach |
| Device Classification | 20220323 |
| Device Code Info | Lot Numbers: 27465196 27566099 27603464 27641141 27731956 27855806 27998506 28297081 GTIN: 8714729776536 |
| Center Classification Date | 20220311 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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