FDA recall Z-1955-2021

Product

Synaptive Trackable Suction Set Standard and Malleable

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-04-23

Report date

2021-07-07

Termination date

2024-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1955-2021