LivaNova SMART PERFUSION PACK INSPIRE 8S - Product recall
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring…
Why was LivaNova SMART PERFUSION PACK INSPIRE 8S - Product recalled?
Perfusion tubing pack was packaged with the incorrect cuvette.
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?
Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette
- Product
- LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring…
- Recalling firm
- LivaNova USA Inc.
- Quantity
- 27 packs
- Distribution
- US Nationwide distribution in the state of IL.
- Recall date
- March 4, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)