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Terminated

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

FDA Recall Z-0599-2016 · Posted None

Recalling FirmNipro Medical Corporation
Recall StatusTerminated
Product CodeFOZ
Date Initiated2014-04-01
Date Terminated2016-12-14
Product Quantity160,000 pieces.

Reason for Recall

Device has the potential to have torn wings.

Firm 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.

Root Cause

Process control

Distribution Pattern

US distribution including TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032777MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLENipro Medical Corp. · 2003-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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