Z-1443-2014Class II

Smiths Medical HOTLINE Fluid Warming Set L-70

Name: Z-1443-2014 Smiths Medical HOTLINE Fluid Warming Set L-70
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-70. 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-1443-2014
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-70. 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: 393,210
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: 2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1443-2014
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)