Recall Z-1080-2015— Arrow International Inc

Name: FDA recall Z-1080-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-05

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2015-01-05, terminated 2018-07-17. It names one FDA 510(k) clearance: K884552. Product: ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.. Reason: The product labeling does not specify the 5 year shelf life of the product..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-05
Terminated: 2018-07-17
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K884552 — CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETERArrow Intl., Inc.·cleared 1989-03-14

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 Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.

Reason for recall

The product labeling does not specify the 5 year shelf life of the product.

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