Boston Scientific Corporation Recall 89468
Description: HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Boston Scientific Corporation Recall 89468 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0760-2022 |
| Event ID | 89468 |
| Event Description | HYDRATOME RX 44-20MM/450CM Material Number: M00583060 |
| 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 | 254 units |
| Recall Reason | Sterility of device is compromised due to a sterile barrier breach |
| Device Classification | 20220323 |
| Device Code Info | Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210 |
| Center Classification Date | 20220311 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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