LivaNova recalls Sorin Stockert Heater-Cooler System 3T units with specific item and serial numbers due to suspected microbial contamination and visible biofilm. Affected units may require cleaning or replacement.
Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.
LivaNova is recalling Sorin Stockert Heater-Cooler System 3T devices that may have microbial contamination and visible biofilm. This could pose a health risk if the equipment is used in medical settings without proper cleaning.
The devices may contain visible biofilm and microbial contamination. This could lead to infections or health issues if the equipment is used in medical settings without proper cleaning.
Healthcare facilities using the Sorin Stockert Heater-Cooler System 3T devices with specific item and serial numbers are most at risk. Patients and staff could be affected if the equipment is not properly cleaned.
Check for item numbers 16-02-81 (240V/60Hz), 16-02-82 (208V/60Hz), or 16-02-85 (120V/60Hz) and serial numbers listed in the recall notice.
Identify the item number and serial number on your Sorin Stockert Heater-Cooler System 3T device to confirm if it is affected.
The devices may contain visible biofilm and microbial contamination, which could pose a health risk if not properly cleaned.
Check the item number and serial number to see if your device is affected. Contact LivaNova for further instructions.
The recall notice mentions the Deep-Cleaning Service is available in the United States, but no specific fix is stated in the record.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1901-2018 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1901-2018 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.
