Recall Z-2170-2017— Arrow International Inc

Name: FDA recall Z-2170-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-04-28, terminated 2018-08-03. It names one FDA 510(k) clearance: K103255. Product: Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters. Reason: Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Terminated: 2018-08-03
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETVasonova, Inc.·cleared 2011-02-18

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

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

Reason for recall

Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.

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