HOTLlNE Disposable Administration Sets recallZ-0425-2012 · Smiths Medical ASD, Inc. · initiated Nov 21, 2011

Terminated All recalls posted in January 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

Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets

FDA root cause category: Device Design

What the company is doing

Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to [email protected]. For questions consignees were instructed to contact Smiths Medical at 1781-763-9330.

Recall details

Recall number: Z-0425-2012
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Nov 21, 2011
Posted by the FDA: Jan 11, 2012
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 36,421 units
Product code: LGZ
FDA submissions: K911383
Distribution: Worldwide Distribution (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel India, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.

Product description

HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.

Code information (models, lots, serial numbers)

Lot Numbers: 1995695 1995696 2038150 2038151 2038152 2047423 2061923 2061924 2061929 2061930 2061931 2061932 2061933 2077201 2077202 2090780 2090781 2095295 2095302 2095306

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-90
Icu Medical, Inc. · Warmer, thermal, infusion fluid
991 reports
Level 1 HL-390
Icu Medical, Inc. · Warmer, thermal, infusion fluid
634 reports
Level 1 L-70
Icu Medical, Inc. · Warmer, thermal, infusion fluid
1 recall385 reports
Level 1 L-70NI
Icu Medical, Inc. · Warmer, thermal, infusion fluid
114 reports
Level 1 L-10
Icu Medical, Inc. · Warmer, thermal, infusion fluid
41 reports
Level 1 L-370
Icu Medical, Inc. · Warmer, thermal, infusion fluid
24 reports
Level 1 HL-390-38
Icu Medical, Inc. · Warmer, thermal, infusion fluid
9 reports
Level 1 HL-90-38
Icu Medical, Inc. · Warmer, thermal, infusion fluid
5 reports
Level 1 HL-390-40
Icu Medical, Inc. · Warmer, thermal, infusion fluid
3 reports
Level 1 HL-90-40
Icu Medical, Inc. · Warmer, thermal, infusion fluid
2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 60516).

Z-0422-2012 · Terminated
HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE R…
Z-0423-2012 · Terminated
HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE…
Z-0424-2012 · Terminated
HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE …
Z-0426-2012 · Terminated
HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE R…
Z-0427-2012 · Terminated
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunctio…
Z-0428-2012 · Terminated
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjuncti…

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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