Recall Z-2338-2017— Arrow International Inc

Name: FDA recall Z-2338-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-09

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-05-09, terminated 2018-09-17. It names one FDA 510(k) clearance: K061289. Product: Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.. Reason: The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Terminated: 2018-09-17
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

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

Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Reason for recall

The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

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