Recall Z-0182-2018— Arrow International Inc

Name: FDA recall Z-0182-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-01

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-06-01, terminated 2020-04-13. It names one FDA 510(k) clearance: K113277. Product: ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. Reason: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Terminated: 2020-04-13
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113277 — ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSArrow International, Inc.·cleared 2012-06-21

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

ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

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