Smiths Medical HOTLINE¿ Fluid Warming Set L-80 — Class II medical device recall Z-1444-2014
Terminated recall by Smiths Medical ASD, Inc., reported 2014-04-16, distributed nationwide. Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may be
| Recall number | Z-1444-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Rockland, MA, United States |
| Recall initiated | 2014-03-17 |
| Classified | 2014-04-09 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2015-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 870 units |
| Reason classes | packaging |
Product
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Reason for recall
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
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-1444-2014. 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.