Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks
Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged, potentially causing blood or IV fluid leaks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leaking blood/IV fluids or dislodged septum) without explicit reports of injury or illness in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the HOTLINE Fluid Warming Set L-70. This medical device is intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions.
The recall is due to a defect where the injection port of the set may leak blood or IV fluids from the septum, or the septum may become dislodged. This issue could compromise the integrity of the fluid delivery system.
Approximately 393,210 units were distributed worldwide, including nationwide distribution in the United States. Users of these devices should stop using the affected sets and contact Smiths Medical for further instructions.
The recalled product
- Product
- Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 393,210
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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