FDA Device recall Z-1684-2021
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dial…
- FDA Device
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dial… by Baxter Healthcare, citing there is a potential leak between the venous patient connector and patient's hemodialysis access.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1684-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-14 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Identifiers
| code_info | Product Code: 101025; Lot 1000276191, UDI: 37332414007837 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1684-2021%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.