Z-1979-2012Class II

Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390

Name: Z-1979-2012 Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390
Creator: Smiths Medical ASD, Inc.
Published: 2012-06-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-06-27 / Terminated / root cause: design

FDA source

Smiths Medical ASD, Inc. began a recall of 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... on 2012-06-27. FDA classified it as Class II and gives the reason as "HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1979-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-27
Posted: 2012-07-09
Terminated: 2014-02-20
Recalling firm: Abbott Medical
Product: 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
Product code: LGZ Warmer, Thermal, Infusion Fluid
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
Root cause tag: design
FDA root cause: Device Design
Action: 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. .
Quantity in commerce: 2247 units
Distribution: US Nationwide Distribution
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1979-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1979-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

Product code LGZ

K911383Class IIHotline Fluid WarmerLevel 1 Technologies, Inc. / cleared 1991-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)