HOTLINE Blood and Fluid Warmer — Class III medical device recall Z-1145-2017
Terminated recall by Smiths Medical ASD, Inc., reported 2017-02-15. HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish la
| Recall number | Z-1145-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2016-10-31 |
| Classified | 2017-02-07 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-11-27 |
| Countries outside the US | FI |
| Quantity | 33 |
| Reason classes | labeling |
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 for recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1145-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.