Z-1166-2007

Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291

Name: Z-1166-2007 Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
Creator: ICU Medical, Inc.
Published: 2006-09-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-09-26 / Terminated

FDA source

ICU Medical, Inc. began a recall of Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 on 2006-09-26. The reason FDA records is "The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1166-2007
Status: Terminated
Initiated: 2006-09-26
Posted: 2007-08-16
Terminated: 2012-03-22
Recalling firm: Abbott Medical
Product: Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
Product code: FPA Set, Administration, Intravascular
Reason for recall: The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
FDA root cause: Other
Action: Firm mailed a letter dated September 26, 2006 to notify customers of the recall. The letter advises the product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. Customers are asked that if they have inventory of the lots identified to quarantine these lots and contact your consignees of this recall and return the product immediately for destruction. They are asked to complete and return the attached product inventory summary sheet in the enclosed self-addressed stamped envelope and return product to ICU Medical.
Quantity in commerce: 26,361 units
Distribution: VA, OH, TX, CA, GA
Product codes and lots: 414371,414372,414373,433069,433070,453469,453470,453471,488549,488550,488551,488552,488553,488554,

Product code FPA

K033290Class IITalon Infusion Set, Model Ip XxxxIcu Medical, Inc. / cleared 2004-04-12

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)