Z-0428-2012

Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL

Name: Z-0428-2012 Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL
Creator: Smiths Medical ASD, Inc.
Published: 2011-11-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-11-21 / Terminated / root cause: design

FDA source

Smiths Medical ASD, Inc. began a recall of Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical... on 2011-11-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0428-2012
Status: Terminated
Initiated: 2011-11-21
Posted: 2012-01-11
Terminated: 2014-08-07
Recalling firm: Abbott Medical
Product: 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 conjunction with Level 1 Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 7631 units
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 codes and lots: Lot Numbers: 2033447 2039136 2046398 2046400 2047961 2047963 2064528 2064529 2064530 2077404 2077405 2077406 2077407 2087667 2099050 2099766 2102361

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)