Recall Z-1955-2021 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Synaptive Medical Inc
Synaptive Trackable Suction Set Standard and Malleable
| Date | Apr 23, 2021 |
| Status | Terminated |
| Reason | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. |
| Root cause | 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 s |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.