Product Safety Recalls

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MY01, INC. Recall 88396

Description: MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

MY01, INC. Recall 88396 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2384-2021
Event ID88396
Event DescriptionMY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Product TypeDevices
DistributionUS Nationwide distribution in the states of MD, OH, CA, NY.
Quantity37 units
Recall ReasonThere 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.
Device Classification20210908
Device Code InfoLot Numbers: 9448532 9448838 9448979 9449000 9449237
Center Classification Date20210827
Recall Initiation Date20210628
Recalling FirmMY01, INC.
Initial Notification Letter
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