Z-0408-03

The following brand name labeled products are under recall (all catalog numbers and all lot numbers under...

Name: Z-0408-03 The following brand name labeled products are under recall (all catalog numbers and all lot numbers under...
Creator: Nipro Corp
Published: 2002-11-08
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2002-11-08 / Terminated

FDA source

Nipro Corp began a recall of The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle... on 2002-11-08. The reason FDA records is "Air or fluid leakage at the hub/needle junction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0408-03
Status: Terminated
Initiated: 2002-11-08
Posted: 2003-05-21
Terminated: 2008-04-15
Recalling firm: Nipro Medical Corporation
Product: The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
Product code: FIE Needle, Fistula
Reason for recall: Air or fluid leakage at the hub/needle junction.
FDA root cause: Other
Action: The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.
Quantity in commerce: 6,984,000
Distribution: Nationwide and Canada
Product codes and lots: All lot numbers in current distribution are under recall.

Product code FIE

K002813Class IINipro Safetouch Safety Fistula NeedleNipro Medical Corp. / cleared 2000-11-21

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)