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Serious recall: Injury is possible or has been reported. Take action promptly.

DIXI MEDICAL USA 2022-02-09 Health serious FDA
Health · FDA · Recall #FDA-Z-0537-2022

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode)… Recall

Issued February 9, 2022 · DIXI MEDICAL USA

In February 2022, DIXI MEDICAL USA recalled the The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode)…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

What you should do

  1. 1 Stop using The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode)… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact DIXI MEDICAL USA to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
DIXI MEDICAL USA
Category
Health
Recall date
February 9, 2022
Units affected
Not reported
Sold at
US Nationwide distribution.
Recall number
FDA-Z-0537-2022
Made in
United States
Issuing agency
FDA

In context

  • DIXI MEDICAL USA has 2 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 870th Health recall we've logged in 2022.
Read the official FDA notice

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