Applied Medical Resources Corp recalls STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated f…

Recall date

January 31, 2020

Source

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

Recall number

Z-2035-2020

FDA classification

Class II

Brand / firm

Applied Medical Resources Corp

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexi…

Why it was recalled

Failure of cardiovascular clips to provide sufficient occlusion of the vessel.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.