FDA-Device2015-09-02Class II

PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound

Arrow International Inc
Hazard

the catheter peel-away component hub tabs may prematurely detach. One injury reported.

Sold states
US Nationwide Distribution and internationally to Canada
Affected count
52109
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2462-2015

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