Synaptive Trackable Suction Set Standard and Malleable
Reported: July 7, 2021 Initiated: April 23, 2021 #Z-1955-2021
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.
Details
- Recalling Firm
- Synaptive Medical Inc
- Units Affected
- 1291 units
- Distribution
- 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
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
Synaptive Trackable Suction Set Standard and Malleable. Recalled by Synaptive Medical Inc. Units affected: 1291 units.
Why was this product recalled? ▼
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1955-2021.
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