Recall Z-0127-2016— Arrow International Inc

Name: FDA recall Z-0127-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-18

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2015-09-18, terminated 2020-06-25. It names 2 FDA 510(k) clearances: K073451, K061289. Product: 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.. Reason: Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-18
Terminated: 2020-06-25
Firm location: Reading, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K073451 — PRESSURE INJECTABLE PICCArrow International, Inc.·cleared 2008-01-15
K061289 — ARROW PRESSURE INJECTABLE PICCArrow International, Inc.·cleared 2006-08-24

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

4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

Reason for recall

Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.

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