LivaNova recalls Inspire 8 Integrated Phisio OXY with HVR Reservoir due to incorrect expiration date printed in the UDI barcode. The expiration date is listed as DDMMYY instead of YYMMDD, though package labels show correct dates.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
LivaNova is recalling Inspire 8 Integrated Phisio OXY oxygenators with specific reservoirs because the expiration date in the UDI barcode is printed incorrectly as DDMMYY instead of the correct YYMMDD format. This could lead to confusion about when the product expires, though the package labels show the correct expiration dates.
The expiration date in the Unique Device Identification (UDI) barcode is printed incorrectly as DDMMYY (day-month-year) instead of the standard YYMMDD (year-month-day) format. This could cause confusion about the product's expiration date, but the package labels show the correct expiration dates.
Patients using the Inspire 8 Integrated Phisio OXY oxygenator with HVR reservoirs that have the specific lot numbers and UDI codes listed in the recall notice are affected. Medical professionals who use these devices in surgeries are most at risk.
Check for the specific lot numbers: 1709190230 or 1710260210, and UDI codes starting with (01)08033178112369(17) followed by the lot number. The product was sold with correct expiration dates on the package labels.
Look for the expiration date on the package labels to confirm it matches the correct format.
The expiration date in the UDI barcode is printed incorrectly as DDMMYY instead of the correct YYMMDD format, though package labels show the correct expiration dates.
The recall is for potential confusion about expiration dates, but the product itself is safe and the package labels show correct expiration dates.
Check for the specific lot numbers: 1709190230 or 1710260210, and UDI codes starting with (01)08033178112369(17) followed by the lot number.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1919-2018 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1919-2018 from LivaNova. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
