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U.S. Department of Health and Human Services

Class 2 Device Recall Synaptive Trackable Suction Set Standard and Malleable

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  Class 2 Device Recall Synaptive Trackable Suction Set Standard and Malleable see related information
Date Initiated by Firm April 23, 2021
Create Date June 25, 2021
Recall Status1 Terminated 3 on January 12, 2024
Recall Number Z-1955-2021
Recall Event ID 87937
Product Classification Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
Product Synaptive Trackable Suction Set Standard and Malleable
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.
Recalling Firm/
Manufacturer		 Synaptive Medical Inc
555 Richmond St West, Suite 800
Toronto Canada
Manufacturer Reason
for Recall		 Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
FDA Determined
Cause 2		 Vendor change control
Action On April 23, 2021 the firm sent a letter to its consignees with the following instructions: 1. Quarantine and discontinue use of all Synaptive Trackable Suction devices. 2. Contact Synaptive Recall Support at 1.866.853.8001 or by email at RecallSupport@synaptivemedical.com. Customer service will schedule an on-site inspection of each device. If this is not possible, arrangements will be made to have all impacted units returned to Synaptive. 3. Once on-site inspection or return of your stock has been arranged, please complete and return the attached Acknowledgement and Receipt Form. All forms should be submitted by email to RecallSupport@synaptivemedical.com. Note: If you are in North America and your account is supported by a Synaptive Clinical Applications Specialist (CAS), then a company representative may have already visited your site and conducted the necessary inspections. If so, we kindly ask that you still complete the Acknowledgement and Receipt Form for our records. 4. Upon inspection, all units will be graded as pass or fail. Units that pass meet normal specifications and are safe for continued use. These devices will be returned and released back into circulation. Failing (i.e. defective) units will be removed immediately and replaced by Synaptive at no cost.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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