Smiths Medical HOTLINE 3 Blood and Fluid Warmer recallZ-1979-2012 · Smiths Medical ASD, Inc. · initiated Jun 27, 2012
Class II Terminated All recalls posted in July 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable
FDA root cause category: Device Design
What the company is doing
Smiths Medical sent an Urgent Medical Device Correction -Field Safety Notice letter dated June 21, 2012 via U.S. Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter included an Urgent Medical Device Field Safety Notice Acknowledgement Form ("Confirmation Form") that customers were instructed to complete and return to Smiths Medical for carrying out the correction and affectivity tracking purposes. The letter stated that a Smiths Medical Representative will visit the affected sites to correct the units with a shelf upgrade kit, which includes instructions and all the parts necessary to make the correction to their affected devices. Customers were provided with a form to record the serial numbers of the devices corrected so that this can be returned to Smiths Medical. For questions regarding this information call Smiths Medical Quality Department at 1-781-763-9335. .
Recall details
- Recall number
- Z-1979-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 27, 2012
- Posted by the FDA
- Jul 9, 2012
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 2247 units
- Product code
- LGZ
- FDA submissions
- K911383
- Distribution
- US Nationwide Distribution
Product description
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 temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
Code information (models, lots, serial numbers)
All serial numbers
Other devices under the same FDA submission
10 devices cleared under K911383 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Level 1 L-10Icu Medical, Inc. · Warmer, thermal, infusion fluid41 reports
- Level 1 L-370Icu Medical, Inc. · Warmer, thermal, infusion fluid24 reports
- Level 1 HL-390-38Icu Medical, Inc. · Warmer, thermal, infusion fluid9 reports
- Level 1 HL-90-38Icu Medical, Inc. · Warmer, thermal, infusion fluid5 reports
- Level 1 HL-390-40Icu Medical, Inc. · Warmer, thermal, infusion fluid3 reports
- Level 1 HL-90-40Icu Medical, Inc. · Warmer, thermal, infusion fluid2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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