Boston Scientific Corporation Recall 89468
Description: JAGTOME RX 44-20-260-035 Material Number: M00573040
Boston Scientific Corporation Recall 89468 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0773-2022 |
| Event ID | 89468 |
| Event Description | JAGTOME RX 44-20-260-035 Material Number: M00573040 |
| 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 | 3578 units |
| Recall Reason | Sterility of device is compromised due to a sterile barrier breach |
| Device Classification | 20220323 |
| Device Code Info | Lot Numbers: 27465198 27515974 27595732 27625064 27720618 27737252 27765472 27833280 27883444 28002224 28296772 27491776 27595731 27618170 27718421 27758432 27764571 27830207 27858381 28002225 28289452 GTIN: 8714729776659 |
| Center Classification Date | 20220311 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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