Z-0251-2007

Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)

Name: Z-0251-2007 Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)
Creator: Smiths Medical ASD, Inc.
Published: 2006-11-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-11-07 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only) on 2006-11-07. The reason FDA records is "IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming". 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-0251-2007
Status: Terminated
Initiated: 2006-11-07
Posted: 2006-12-06
Terminated: 2009-11-30
Recalling firm: Abbott Medical
Product: Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)
Product code: FPA Set, Administration, Intravascular
Reason for recall: IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Smiths Medical ASD notified Direct customers and distributors via letter sent by UPS on or about November 6, 2006 and the days following as necessary until all consignees are notified. Letters to direct customers will be addressed to the Risk Manager. All Smiths Medical affiliates contacted by e-mail and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product. US Distributors instructed to return the affected product and to provide a customer list. Foreign distributors instructed to return the affected product and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product.
Quantity in commerce: 13,640 units
Distribution: Worldwide, including USA, Japan, Canada, Ireland, UK, Finland, Netherlands, Germany, Austria, Portugal, France, Sweden, Australia, New Zealand, Russia, Italy, Singapore, Kuwait, Saudi Arabia, Czech Republic, Dubai, Spain, Norway, Denmark, and East Temor.
Product codes and lots: Lot number: 725769, 1011870, 1019492, 1011871, 1027190, 1028662, 1037117, 1037809, 1049619, 1058925, 1060998, 1064376, 1067796, 1067797, 1074088, 1074089

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)