Recall Z-2096-2016— Stryker Sustainability Solutions

Name: FDA recall Z-2096-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-01

Class I · Terminated

Class I FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-06-01, terminated 2016-10-19. It names one FDA 510(k) clearance: K001578. Product: AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203. Reason: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient..

Recalling firm: Stryker Sustainability Solutions
Classification: Class I
Status: Terminated
Initiated: 2016-06-01
Terminated: 2016-10-19
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K001578 — ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETERAngioDynamics, Inc.·cleared 2000-10-13

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

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

Reason for recall

Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

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