Recall Z-0207-2016— Arrow International Inc

Name: FDA recall Z-0207-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-16

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2015-10-16, terminated 2017-11-09. It names 5 FDA 510(k) clearances: K132133, K122854, K121941 and 2 more. Product: ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.. Reason: Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-16
Terminated: 2017-11-09
Firm location: Reading, PA, United States

510(k) clearances named in this recall

5 on FDA's record

K132133 — CG+ ARROW JACC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·cleared 2013-09-26
K122854 — ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCERArrow International (Subsidiary of Teleflex Inc.)·cleared 2013-01-04
K121941 — ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·cleared 2012-09-07
K113277 — ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSArrow International, Inc.·cleared 2012-06-21
K112896 — ARRW EVOLUTIONArrow International (Subsidiary of Teleflex Inc.)·cleared 2012-05-10

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 PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

Reason for recall

Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

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