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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