FDA Device recall Z-1118-2021
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the P…
- FDA Device
- Class II
- ongoing
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the P… by Baxter Healthcare, citing complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1118-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-30 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Identifiers
| code_info | UDI 07332414007836, All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.