FDA Device recall Z-1145-2017
HOTLINE Blood and Fluid Warmer, Mole l HL-90
- FDA Device
- Class III
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class III recall of HOTLINE Blood and Fluid Warmer, Mole l HL-90 by Smiths Medical Asd, citing HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-31 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
Reason
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Identifiers
| code_info | S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2017%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.