Recall Z-1244-2020— Arrow International Inc

Name: FDA recall Z-1244-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2019-12-20, terminated 2021-02-25. It names one FDA 510(k) clearance: K884552. Product: Arrow EPIDURAL NEEDLE COMPONENT AN-05505. Reason: Product lidstock contains the incorrect expiration date for the product.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-20
Terminated: 2021-02-25
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 AN-05505

Reason for recall

Product lidstock contains the incorrect expiration date for the product

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