Z-1444-2014Class II

Smiths Medical HOTLINE Fluid Warming Set L-80

Name: Z-1444-2014 Smiths Medical HOTLINE Fluid Warming Set L-80
Creator: Smiths Medical ASD, Inc.
Published: 2014-03-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-03-17 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures... on 2014-03-17. FDA classified it as Class II and gives the reason as "Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1444-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-17
Posted: 2014-04-09
Terminated: 2015-06-09
Recalling firm: Abbott Medical
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
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Smiths Medical issued Urgent Field Safety Notice Recall on 3/17/14 via mail service. Distributors will be instructed to notify their customers. The Field Safety Notice will also include an Urgent Recall Notice Confirmation Form (Confirmation Form) that consignees will be instructed to send back to Smiths Medical for carrying out the action and tracking effectiveness.Accounts are to inspect inventory and return recalled product. If you should have any questions regarding this information, please contact Shirley Duggan, Quality System Engineer at 1-781-763-9335 or by E-Mail [email protected].
Quantity in commerce: 870 units
Distribution: Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
Product codes and lots: 2513261 2531612 2540540 2545044 2588656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1444-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1443-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-09
Z-1444-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-09

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