Synaptive Trackable Suction Set Standard and Malleable
This recall has been terminated (originally issued April 23, 2021).
- Company
- Synaptive Medical Inc
- Recall Initiated
- April 23, 2021
- Terminated
- January 12, 2024
- Recall Number
- Z-1955-2021
- Quantity
- 1291 units
- Official Source
- View on FDA website ↗
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
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.
Root Cause
Vendor change control
Action Taken
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.