Baxter Healthcare Corporation Recall 87150
Description: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Baxter Healthcare Corporation Recall 87150 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1121-2021 |
| Event ID | 87150 |
| Event Description | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 211155 devices |
| Recall Reason | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Device Classification | 20210224 |
| Device Code Info | UDI 07332414085216, All lots within expiry |
| Center Classification Date | 20210216 |
| Recall Initiation Date | 20201230 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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