Summary
The FDA issued a Class II for Synaptive Trackable Suction Set Standard and Malleable by Synaptive Medical Inc. Reason: Due to visible burrs/metal filings affixed along the suction tube inner perimeter..
Details
Source
Device Recall
External ID
Z-1955-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
Synaptive Trackable Suction Set Standard and Malleable
Lot/Code Info: 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.
Quantity Affected: 1291 units
Reason for Recall
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-23
Company
Toronto, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Synaptive Medical Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Synaptive Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Synaptive Medical Inc have FDA actions?
Synaptive Medical Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1955-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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