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U.S. Department of Health and Human Services

Class 2 Device Recall LIPOSORBER LA15 System

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  Class 2 Device Recall LIPOSORBER LA15 System see related information
Date Initiated by Firm February 17, 2022
Create Date April 09, 2022
Recall Status1 Terminated 3 on May 06, 2024
Recall Number Z-0900-2022
Recall Event ID 89735
PMA Number P910018 
Product Classification Lipoprotein, low density, removal - Product Code MMY
Product 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 for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS,
2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS
Code Information All product lot and UDI numbers are affected.  
Recalling Firm/
Manufacturer		 Kaneka America Corp
546 5th Ave Fl 21
New York NY 10036-5000
For Additional Information Contact Ahmad Al-Sattari
212-7054355
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Error in labeling
Action 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
Quantity in Commerce 138 Systems, 54703 disposables
Distribution US only: CA, NH, CT, MA, FL, DE, NY, NJ, PA, OH, MD, VA, NC, SC, GA, MS, TN, TX, IN, AZ, MI, WI, MN, IL, MO, NE, CO, WA, OR, UT, KS, OK, AL, ME
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MMY and Original Applicant = KANEKA PHARMA AMERICA CORP.
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