Z-0599-2016Class III

NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC

Name: Z-0599-2016 NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC
Creator: Nipro Medical Corporation
Published: 2014-04-01
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2014-04-01 / Terminated / root cause: manufacturing process

FDA source

Nipro Medical Corporation began a recall of NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC on 2014-04-01. FDA classified it as Class III and gives the reason as "Device has the potential to have torn wings". 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-0599-2016
Classification: Class III
Status: Terminated
Initiated: 2014-04-01
Posted: 2016-01-06
Terminated: 2016-12-14
Recalling firm: Nipro Medical Corporation
Product: NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Device has the potential to have torn wings.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The only one Distributor was notified (2014) by e-mail by the firm of the quality deficiency before the product arrived at their facility. It was immediately returned to Nipro Medical when it arrived.
Quantity in commerce: 160,000 pieces.
Distribution: US distribution including TN.
Product codes and lots: Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0599-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2016	Class III	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code FOZ

K032777Class IIModification to: Nipro Safe Touch Safety Fistula NeedleNipro Medical Corp. / cleared 2003-11-14

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)