Recall Z-2771-2016— Arrow International Inc

Name: FDA recall Z-2771-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2016-02-17, terminated 2017-10-18. It names one FDA 510(k) clearance: K061289. Product: Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components. Reason: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Terminated: 2017-10-18
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

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

Reason for recall

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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