FDA-Device2021-07-07Class II
Synaptive Trackable Suction Set Standard and Malleable
Synaptive Medical Inc
Hazard
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Sold states
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
Affected count
1291 units
Manufactured in
555 Richmond St West, Suite 800, N/A, Toronto, N/A, Canada
Products
Synaptive Trackable Suction Set Standard and Malleable
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1955-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief