# FDA recall Z-0900-2022

> **Kaneka America Corp** · Class II · device recall initiated 2022-02-17.

## 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

## 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.

## 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

## Key facts

- **Recall number:** Z-0900-2022
- **Recalling firm:** Kaneka America Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-17
- **Report date:** 2022-04-20
- **Termination date:** 2024-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0900-2022

## Citation

> AI Analytics. FDA recall Z-0900-2022. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0900-2022. Source: US FDA. Licensed CC0.

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