Reported Feb 19, 2020 · Terminated
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The…
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 Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594
- Product UsageThe S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours
- Lot codes and dates
- Device Model, Catalog Number
- Serial Number
SORIN CONNECT DPIII KOMPL. S524-90-8017BQC0247 SORIN CONNECT DPIII KOMPL. S524-90-8017BQC0249 SORIN CONNECT DPIII KOMPL. S524-90-8017BQC0250 SORIN CONNECT DPIII KOMPL. S524-90-8017BQC0258 DATAPADIII WITHOUT SOFTWARE24-90-8717BQC0257
- Amount recalled
- 5 Datapads
Where it was sold
Why it was recalled
Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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