Stryker Sustainability Solutions recalls AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

Recall date

June 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2096-2016

FDA classification

Class I

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203