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Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and f

FDA device recall Z-0161-2016 · posted 2015-10-23 · Terminated

Recall details

Recalling firm
Nipro Medical Corporation
Reason for recall
Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Action taken
Customers were issued a RMA 60001203 on August 18, 2015.
Root cause
Mixed-up of materials/components
Status
Terminated
Product code
LLB
Quantity affected
50,000 pieces
Distribution
Indiana
Date initiated
2015-08-13
Date posted
2015-10-23
Date terminated
2017-10-13
Location
Miami, FL

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Related 510(k) clearances

RecordFirmDate
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE (K071145)Nipro Medical Corporation2007-09-07