VAMPIRO V5001-minimally invasive poole suction sleeve recall: Sterility Concern
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Why was VAMPIRO V5001-minimally invasive poole suction sleeve recalled?
Lack of package integrity may compromise sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205
- Product
- VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
- Recalling firm
- Santanello Surgical LLC
- Quantity
- 98
- Distribution
- FL,OK, OH, NY, ME, MN, WI
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)