Z-1996-2014Class II

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set

Name: Z-1996-2014 Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set
Creator: RGI Medical Manufacturing, Inc.
Published: 2014-03-28
License: https://open.fda.gov/license/

RGI Medical Manufacturing, Inc. / initiated 2014-03-28 / Terminated / root cause: manufacturing process

FDA source

RGI Medical Manufacturing, Inc. began a recall of Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures on 2014-03-28. FDA classified it as Class II and gives the reason as "Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use". 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-1996-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-28
Posted: 2014-07-07
Terminated: 2016-09-29
Recalling firm: RGI Medical Manufacturing, Inc.
Product: Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI
Quantity in commerce: 19,200 units.
Distribution: US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
Product codes and lots: Lot numbers 102131 and 110531.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1996-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1996-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-06

Product code FPA

K001599Class IIActi-Flex IV Administration SetR-Group Intl. / cleared 2000-09-18

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)