Z-1145-2017Class III

HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70...

Name: Z-1145-2017 HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70...
Creator: Smiths Medical ASD, Inc.
Published: 2016-10-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-10-31 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.)... on 2016-10-31. FDA classified it as Class III and gives the reason as "HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1145-2017
Classification: Class III
Status: Terminated
Initiated: 2016-10-31
Posted: 2017-02-07
Terminated: 2017-11-27
Recalling firm: Abbott Medical
Product: HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Smiths Medical sent an Urgent-Medical Device Field Safety Notice dated October 28, 2016, to all affected customers. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to notify customers and to review and complete the Recall Confirmation Form and return it to Smith Medical via e-mail to [email protected]. For further questions, please call (651) 633-2556.
Quantity in commerce: 33
Distribution: Internationally to Finland
Product codes and lots: S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1145-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1145-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-07

Product code LGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)