Z-0709-03

Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936

Name: Z-0709-03 Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
Creator: I-Flow Corporation
Published: 2003-03-05
License: https://open.fda.gov/license/

Halyard Health / initiated 2003-03-05 / Terminated

FDA source

I-Flow Corporation began a recall of Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936 on 2003-03-05. The reason FDA records is "Wrong component may result in over infusion of medications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0709-03
Status: Terminated
Initiated: 2003-03-05
Posted: 2003-04-03
Terminated: 2004-12-01
Recalling firm: Halyard Health
Product: Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
Product code: FRN Pump, Infusion
Reason for recall: Wrong component may result in over infusion of medications.
FDA root cause: Other
Action: Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.
Quantity in commerce: 5,808 units
Distribution: States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.
Product codes and lots: Lot numbers: 262111 (manufactured June 2002, expires May 2005) 282233 (manufactured August 2002, expires July 2005)

Product code FRN

K923875Class IISidekick 50 Plus and Sidekick 100 PlusI-Flow Corp. / cleared 1993-05-13

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)