LivaNova recalls Smart Perfusion Pack E-Packs with incorrect expiration dates on labels. This may lead to improper use if the product expires before intended use. Affected units include specific model numbers and lots.
The product is labeled with the incorrect expiration date.
LivaNova is recalling Smart Perfusion Pack E-Packs that have incorrect expiration dates on their labels. This could cause the product to expire before intended use, potentially leading to improper medical treatment.
The product is labeled with the wrong expiration date, which could mean the device expires before it's supposed to. This might lead to using a device that's no longer safe or effective for medical procedures.
Healthcare professionals using the Smart Perfusion Pack E-Packs for medical procedures are most likely affected. Patients receiving treatment with these devices may be at risk if the expiration date is incorrect.
Check the label for the product name 'Smart Perfusion Pack E-Pack', model number REF 088511400, revision L, and specific lot numbers 1717800062 or 1720800071. The expiration date on the label may be incorrect.
Look for the product name, model number, and lot numbers on the label to confirm if it's affected.
The product is labeled with the incorrect expiration date, which could lead to improper use if the product expires before intended use.
Check the label for the product name, model number, and lot numbers to confirm if it's affected. If it is, contact LivaNova for further instructions.
The recall is for an incorrect expiration date label, which is a low-risk issue. There is no indication of serious injury risk in normal use.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0664-2018 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0664-2018 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.
