Food, drugs, devices › Smiths Medical ASD, Inc.
Device recall: Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the
FDA enforcement event 62389 is a device recall by Smiths Medical ASD, Inc. of Rockland, MA, initiated 27 Jun 2012 and classified Class II, with 1 product record.
FDA defines Class II as 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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 20 Feb 2014. Initiation: voluntary: firm initiated. Smiths Medical ASD, Inc. has 108 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Smiths Medical ASD, Inc., Rockland, MA.
Reason for recall
"HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable"
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1979-2012 | Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic… | 2247 units | Class II | Terminated | 18 Jul 2012 |
Context
Other enforcement events for Smiths Medical ASD, Inc.
All 108 events for Smiths Medical ASD, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Feb 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.