FDA Device recall Z-1145-2022
3,65 m Extension Set with Luer-lock Connector
- FDA Device
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of 3,65 m Extension Set with Luer-lock Connector by Baxter Healthcare, citing certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-21 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
3,65 m Extension Set with Luer-lock Connector
Reason
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Identifiers
| code_info | Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024) |
|---|
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-1145-2022%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.