XVIVO Organ Chamber REF 19020 with incomplete weld seal may not be sterile. Affected units include specific lot numbers. Stop using immediately to avoid contamination risks.
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
XVIVO Organ Chamber REF 19020 units with incomplete weld seals could be contaminated. This affects safety during medical procedures as the product may not be sterile.
The weld seal was incomplete, meaning the product might not be sterile. This could lead to contamination during medical procedures, posing infection risks to patients and staff.
Medical professionals using the XVIVO Organ Chamber REF 19020 for organ perfusion are at risk. Patients receiving procedures with these units could face infection.
Check for lot numbers 13801-13806 on the packaging. The product has model number 19020 and unique identifiers starting with (01)07350069520074.
Immediately discard the XVIVO Organ Chamber REF 19020 units with incomplete weld seals to prevent contamination risks.
The weld seal was incomplete, which means the product may not be sterile and could lead to contamination during medical procedures.
Units with lot numbers 13801 through 13806 and model number 19020.
Check the packaging for lot numbers 13801-13806 or unique identifiers starting with (01)07350069520074.
We’ve drafted a message you can send XVIVO to request your refund or repair — edit it as you like.
Subject: Recall Z-1212-2022 — XVIVO XVIVO Hello, I own a XVIVO that is covered by recall Z-1212-2022 from XVIVO. 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.
