Reported Jul 7, 2021 · Terminated

Synaptive Trackable Suction Set Standard and Malleable

Synaptive Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synaptive Medical Inc · 555 Richmond St West, Suite 800 · Toronto, N/A · N/A

Is this the product you have?

  • Synaptive Trackable Suction Set Standard and Malleable
Lot codes and dates
  • Set and components codesSYN-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
Amount recalled
1291 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 12, 2024 · Data as of Sep 19, 7:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.