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.
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 or dislodged septum) without reported injuries or illnesses in the source text, which aligns with 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 870 units of the HOTLINE Fluid Warming Set L-80. This medical device is intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions.
The recall was initiated because the injection port of the set may leak blood or IV fluids from the septum, or the septum may become dislodged. The affected units were distributed worldwide, including in the United States in the states of AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, and TW.
The specific lot codes associated with this recall are 2513261, 2531612, 2540540, 2545044, and 2588656. Healthcare facilities and consumers should check their inventory for these specific codes and stop using the affected sets.
The recalled product
- 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
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 870
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2513261 2531612 2540540 2545044 2588656
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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