Kaneka recalls LIPOSORBER LA-15 LDL Adsorption Columns for patients on ACE inhibitors due to risk of severe anaphylactoid reactions including shock.
Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.
Kaneka is recalling its LIPOSORBER LA-15 system because it can cause severe allergic reactions in patients taking ACE inhibitor medications. This risk requires immediate attention to prevent life-threatening reactions.
The LIPOSORBER LA-15 LDL Adsorption Column can cause severe anaphylactoid reactions, including shock, when used with ACE inhibitor medications. This reaction can be life-threatening and requires immediate medical attention.
Patients using the LIPOSORBER LA-15 system with ACE inhibitor medications are at risk. Those with a history of severe allergic reactions may also be affected.
Check for the LIPOSORBER LA-15 system with product numbers 101445 (MA-03) and disposables like #101447, #101473, #101785, #101786, #101788, or #101789. All product lot and UDI numbers are affected.
If you experience symptoms like swelling, difficulty breathing, or shock after using the LIPOSORBER LA-15 system with ACE inhibitors, seek immediate medical help.
Reach out to Kaneka America Corp for guidance on the recall and potential remedies.
The LIPOSORBER LA-15 system can cause severe anaphylactoid reactions, including shock, in patients taking ACE inhibitor medications.
Check for symptoms of anaphylactoid reactions and contact Kaneka America Corp for guidance.
Yes, the product numbers include 101445 (MA-03) and disposables like #101447, #101473, #101785, #101786, #101788, or #101789.
We’ve drafted a message you can send Kaneka to request your refund or repair — edit it as you like.
Subject: Recall Z-0900-2022 — Kaneka Kaneka Hello, I own a Kaneka that is covered by recall Z-0900-2022 from Kaneka. 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.
