| Date Initiated by Firm |
June 10, 2019 |
| Create Date |
August 09, 2019 |
| Recall Status1 |
Terminated 3 on January 13, 2021 |
| Recall Number |
Z-2237-2019 |
| Recall Event ID |
83051 |
| Product Classification |
Catheter and tip, suction - Product Code JOL
|
| Product |
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter |
| Code Information |
Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205 |
Recalling Firm/
Manufacturer |
Santanello Surgical LLC
4664 Hayden Run Rd
Columbus OH 43221-5937
|
| For Additional Information Contact |
SAME
614-204-7360
|
Manufacturer Reason
for Recall |
Lack of package integrity may compromise sterility
|
FDA Determined
Cause 2 |
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 in Commerce |
98 |
| Distribution |
FL,OK, OH, NY, ME, MN, WI |
| 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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