FDA Device recall Z-1653-2022
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403
- FDA Device
- Class I
- terminated
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class I recall of Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403 by Baxter Healthcare, citing firm noted an increase in customer reports of leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1653-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-08-09 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Reason
Firm noted an increase in customer reports of leaks.
Identifiers
| code_info | UDI/DI 00085412656649, 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: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1653-2022%22
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