Kaneka America Corp LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 02/17/2022 a recall notification letter with revised labeling was emailed regarding contraindication in patients who are being treated with angiotensin-converting enzyme (ACE) inhibitors. Customers are to locate, destroy and replace all operator's manuals, patient guides, and IFUs with those attached to the recall notice, ensuring they are distributed to all end users. All device model, lot, and UDI numbers for systems and disposables are affected. Submit the Acknowledgement and Receipt Form to Kaneka Medical America, LLC via email. If you have any question or concerns about this recall please contact Kaneka Medical America LLC Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time, at: Phone: (212) 705-4355, Email: Ahmad.Al-Sattari@kaneka.com

Distribution

As reported by FDA

AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI