Recall Z-1955-2021— Synaptive Medical Inc

Class II · Terminated

Class II FDA medical device recall by Synaptive Medical Inc, initiated 2021-04-23, terminated 2024-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Synaptive Trackable Suction Set Standard and Malleable. Reason: Due to visible burrs/metal filings affixed along the suction tube inner perimeter..

Recalling firm
Synaptive Medical Inc
Classification
Class II
Status
Terminated
Initiated
2021-04-23
Terminated
2024-01-12
Firm location
Toronto, N/A, Canada

Product description

Synaptive Trackable Suction Set Standard and Malleable

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.