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Terminated

Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.

FDA Recall Z-0161-2016 · Posted 2015-10-23

Recalling FirmNipro Medical Corporation
Recall StatusTerminated
Product CodeLLB
Date Initiated2015-08-13
Date Terminated2017-10-13
Product Quantity50,000 pieces

Reason for Recall

Some 1 1/4" needles were packaged and labeled in the 1" blister package.

Firm Action

Customers were issued a RMA 60001203 on August 18, 2015.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Indiana

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071145NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLENipro Medical Corporation · 2007-09-07

Official Source

View FDA Recall →

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

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