Z-0900-2022Class II

LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and...

Name: Z-0900-2022 LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and...
Creator: Kaneka America Corp
Published: 2022-02-17
License: https://open.fda.gov/license/

Kaneka Medical America LLC / initiated 2022-02-17 / Terminated / root cause: labeling and UDI

FDA source

Kaneka America Corp began a recall of LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux... on 2022-02-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0900-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-17
Posted: 2022-04-09
Terminated: 2024-05-06
Recalling firm: Kaneka Medical America LLC
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
Product code: MMY Lipoprotein, Low Density, Removal
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.
Root cause tag: labeling and UDI
FDA root cause: 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: [email protected]
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
Product codes and lots: All product lot and UDI numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0900-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0900-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-08

Product code MMY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)