Recall Z-2462-2015— Arrow International Inc

Name: FDA recall Z-2462-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-30

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2015-07-30, terminated 2018-06-28. It names 6 FDA 510(k) clearances: K121941, K103658, K103255 and 3 more. Product: PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound. Reason: the catheter peel-away component hub tabs may prematurely detach. One injury reported..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-30
Terminated: 2018-06-28
Firm location: Reading, PA, United States

510(k) clearances named in this recall

6 on FDA's record

K121941 — ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·cleared 2012-09-07
K103658 — FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERTeleflex, Inc.·cleared 2012-05-16
K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETVasonova, Inc.·cleared 2011-02-18
K073451 — PRESSURE INJECTABLE PICCArrow International, Inc.·cleared 2008-01-15
K061289 — ARROW PRESSURE INJECTABLE PICCArrow International, Inc.·cleared 2006-08-24
K042126 — PICCArrow Intl., Inc.·cleared 2004-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.