Boston Scientific Corporation Recall 88369
Description: TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Boston Scientific Corporation Recall 88369 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2327-2021 |
| Event ID | 88369 |
| Event Description | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. |
| Quantity | 4980 sets |
| Recall Reason | Potential for leaks and loosening at the patient catheter connection |
| Device Classification | 20210825 |
| Device Code Info | GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E |
| Center Classification Date | 20210819 |
| Recall Initiation Date | 20210723 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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