Recall Z-2804-2020— Arrow International Inc

Name: FDA recall Z-2804-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-06

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2020-07-06, terminated 2021-11-05. It names one FDA 510(k) clearance: K020430. Product: NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.. Reason: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Terminated: 2021-11-05
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)Diatek, Inc.·cleared 2002-05-09

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

NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.

Reason for recall

The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

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