Recall Z-2698-2017— Arrow International Inc

Name: FDA recall Z-2698-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-12

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-06-12, terminated 2018-09-06. It names one FDA 510(k) clearance: K112896. Product: Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology. Reason: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the 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..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Terminated: 2018-09-06
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

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 EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Reason for recall

Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the 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.

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