Summary
The FDA issued a Class II for MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 by MY01, INC.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2384-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Lot/Code Info: Lot Numbers: 9448532 9448838 9448979 9449000 9449237
Quantity Affected: 37 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of MD, OH, CA, NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-28
Company
Montreal, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MY01, INC. has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MY01, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MY01, INC. have FDA actions?
MY01, INC. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2384-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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