FDA Device recall Z-1119-2021
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment usi…
- FDA Device
- Class II
- ongoing
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment usi… 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-1119-2021 |
| 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 Single Needle Conversion Kit, product code 101290 - 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 07332414007881, 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-1119-2021%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.