Recall Z-1812-2019— Arrow International Inc

Name: FDA recall Z-1812-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-23

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2019-04-23, terminated 2021-01-13. It names one FDA 510(k) clearance: K132133. Product: Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM. Reason: Lidstock states the incorrect expiration date for the product.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2019-04-23
Terminated: 2021-01-13
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K132133 — CG+ ARROW JACC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·cleared 2013-09-26

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¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM

Reason for recall

Lidstock states the incorrect expiration date for the product

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