HOTLlNE Disposable Administration Sets, Product Codes L-70 recallZ-0422-2012 · 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-0422-2012
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: 449,307 sets
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 Codes L-70 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)

Show the full code information (1k characters)

Lot Numbers: 1961565 1967233 1967234 1967235 1967236 1967237 1967238 1967239 1967240 1973118 1973119 1982938 1982939 1983243 1983244 1983246 1989241 1989242 1989243 1989244 1989245 1995431 1995554 1995555 1995556 1995698 1995699 1995700 1995701 1995702 2007275 2007276 2007277 2007278 2019640 2019641 2019642 2019643 2019644 2025123 2025125 2025126 2025127 2025128 2025129 2025130 2025131 2025133 2025134 2025135 2033081 2033082 2033083 2033084 2033085 2033086 2042613 2042614 2042615 2042617 2042618 2049316 2049317 2049318 2049437 2049438 2055173 2055174 2055175 2055176 2059473 2059474 2059475 2064014 2064015 2064017 2064018 2068138 2068139 2068140 2068141 2068142 2077203 2077204 2077205 2077206 2077207 2083507 2083508 2084305 2090782 2090783 2093663 2093664 2095298 2095300 2101204 2101205 2101206 2101207 2101208

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-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-0425-2012 · Terminated
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 …
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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