Kaneka America Corp 2022-04-20 Health serious FDA
Health · FDA · Recall #FDA-Z-0900-2022
LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445… Recall
Issued April 20, 2022 · Kaneka America Corp
In April 2022, Kaneka America Corp recalled the LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Kaneka America Corp to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Kaneka America Corp
- Category
- Health
- Recall date
- April 20, 2022
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-0900-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Kaneka America Corp has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.