STERILMED, INC. recalls Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive a…

Recall date

April 26, 2016

Source

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

Recall number

Z-1846-2016

FDA classification

Class II

Brand / firm

STERILMED, INC.

Sold / distributed

US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI. Canada

Why it was recalled

Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.

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

What was recalled

Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.