Recall Z-2237-2019 ยท JOL Catheter And Tip, Suction
Santanello Surgical LLC
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
| Date | Jun 10, 2019 |
| Status | Terminated |
| Reason | Lack of package integrity may compromise sterility |
| Root cause | Package design/selection |
| Action | Santanello Surgical issued recall letter dated 6/10/19 stating reason for recall, health risk and action to take: immediately examine inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Email contact@vampirosuction.com for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832. |
| Quantity | 98 |
| Distribution | FL,OK, OH, NY, ME, MN, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.