Reported Mar 4, 2020 · Terminated
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in…
LivaNova USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova USA Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- LivaNova SMART PERFUSION
- PACK INSPIRE 8S - Product UsageThe affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood
- Lot codes and dates
- Model Number046008200
- Lot Number1912100141
- UDI(01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette
- Amount recalled
- 27 packs
Where it was sold
- Nationwide
- IL
Why it was recalled
Perfusion tubing pack was packaged with the incorrect cuvette.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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