Boston Scientific Corporation Recall 89468
Description: HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Boston Scientific Corporation Recall 89468 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0759-2022 |
| Event ID | 89468 |
| Event Description | HYDRATOME RX 44-20MM/260CM Material Number: M00583040 |
| 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 | 7695 units |
| Recall Reason | Sterility of device is compromised due to a sterile barrier breach |
| Device Classification | 20220323 |
| Device Code Info | Lot Numbers: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197 |
| Center Classification Date | 20220311 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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