FDA-Device2018-02-21Class II

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

Arrow International Inc
Hazard

Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Sold states
US nationwide distribution.
Affected count
2691 total
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0601-2018

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