Recall Z-2032-2018— Arrow International Inc

Name: FDA recall Z-2032-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-11

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-04-11, terminated 2020-05-15. It names one FDA 510(k) clearance: K780532. Product: 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S. Reason: Product sterility may be compromised due to unsealed packaging..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Terminated: 2020-05-15
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

9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S

Reason for recall

Product sterility may be compromised due to unsealed packaging.

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