Recall Z-2576-2018— Arrow International Inc

Name: FDA recall Z-2576-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-23

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-05-23, terminated 2020-05-20. It names one FDA 510(k) clearance: K780532. Product: Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.. Reason: Product contains dry natural rubber latex. Label states Latex Free..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-23
Terminated: 2020-05-20
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K780532 — PERCUTANEOUS SHEATH INTRODUCER KITArrow Intl., Inc.·cleared 1978-04-21

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

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

Reason for recall

Product contains dry natural rubber latex. Label states Latex Free.

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