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Recall Observatory FDA recall evidence

Device product

Synaptive Trackable Suction Set Standard and Malleable

Z-1955-2021

April 23, 2021

Class II

Product summary

Firm
Synaptive Medical Inc
Event
Event 87937
Status
Terminated
Classification
Class II
Quantity
1291 units
Official record key
device-enforcement:Z-1955-2021

Official wording

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

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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