FDA-Device2014-06-25Class II

NIPRO Safe Touch Safety Scalp Vein Set

Nipro Medical Corporation
Hazard

There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.

Sold states
Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
Affected count
176,000 pieces
Manufactured in
3150 Nw 107th Ave, N/A, Miami, FL, United States
Products
NIPRO Safe Touch Safety Scalp Vein Set

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2014

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