Synaptive Medical Inc recalls Synaptive Trackable Suction Set Standard and Malleable

Recall date

April 23, 2021

Source

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

Recall number

Z-1955-2021

FDA classification

Class II

Brand / firm

Synaptive Medical Inc

Sold / distributed

Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam

Why it was recalled

Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

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

What was recalled

Synaptive Trackable Suction Set Standard and Malleable