Z-1955-2021 Class II Terminated

Recalled by Synaptive Medical Inc — Toronto, N/A

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
April 23, 2021
Termination Date
January 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1291 units

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.

Distribution Pattern

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

Code Information

Set and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers.