Arrow International Inc recalls ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and C…

Recall date

July 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0602-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.