MY01 recalls specific model pressure monitors with a faulty needle that may need more force to penetrate skin. Affected units include lot numbers 9448532, 9448838, 9448979, 9449000, 9449237.
There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.
MY01 recalls certain continuous compartmental pressure monitors due to a faulty needle that may require more force to penetrate skin. This could lead to discomfort or injury during use if the needle is too stiff.
The affected devices have needles with a geometry that doesn't meet specifications. This means the needle might need more force to penetrate skin, potentially causing discomfort or minor injury during use.
Users of the MY01 Continuous Compartmental Pressure Monitor with the listed lot numbers are affected. Patients using these monitors for medical purposes may be at slightly higher risk during needle insertion.
Check the lot number on your device. Affected units include 9448532, 9448838, 9448979, 9449000, and 9449237. The product is a continuous compartmental pressure monitor from MY01, Inc.
Identify the lot number on your device to see if it matches the affected numbers: 9448532, 9448838, 9448979, 9449000, 9449237.
The recalled monitors have needles with a geometry that is out of specification, which may require more force to penetrate skin.
Check the lot number on your device. Affected units include 9448532, 9448838, 9448979, 9449000, and 9449237.
The recall does not specify a remedy, so contact MY01, Inc. for further instructions.
We’ve drafted a message you can send MY01 to request your refund or repair — edit it as you like.
Subject: Recall Z-2384-2021 — MY01 MY01 Hello, I own a MY01 that is covered by recall Z-2384-2021 from MY01. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
