Synaptive Medical Inc Recall 87937
Description: Synaptive Trackable Suction Set Standard and Malleable
Synaptive Medical Inc Recall 87937 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1955-2021 |
| Event ID | 87937 |
| Event Description | Synaptive Trackable Suction Set Standard and Malleable |
| Product Type | Devices |
| 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 |
| Quantity | 1291 units |
| Recall Reason | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. |
| Device Classification | 20210707 |
| Device 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. |
| Center Classification Date | 20210625 |
| Recall Initiation Date | 20210423 |
| Recalling Firm | Synaptive Medical Inc |
| Initial Notification | |
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