Recall Z-1228-2017— Arrow International Inc

Name: FDA recall Z-1228-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-11

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-01-11, terminated 2018-09-06. It names one FDA 510(k) clearance: K930129. Product: Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.. Reason: There have been complaints for peel away sheaths flaring.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Terminated: 2018-09-06
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K930129 — ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERArrow Intl., Inc.·cleared 1994-03-28

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

Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.

Reason for recall

There have been complaints for peel away sheaths flaring

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