FDA-Device2015-09-09Class II

Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days

Arrow International Inc
Hazard

saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

Sold states
Worldwide Distribution - US nationwide and Internationally to Canada.
Affected count
92902
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2489-2015

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