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Questioning how to update customers, if UTAK will send it out or if they have to
Oct 07, 2025 03:38 PM
Hi Patti,
An official response to this is pending our teams review. Part of our process is a recall and mandatory device reporting evaluation. Based on past experience my best guess is this will come with an updated IFU and a correction letter explaining the issue.
Once confirmed we can determine how to proceed. Generally, we would send it to you and ask you to forward along to anyone you further distributed to. If you prefer, I am sure we can work out getting a list of emails from you and sending them ourselves. I’ll keep you posted!
Thank you,
Andrew Hartmann
Business Development Manager
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25020 Avenue Tibbitts
Valencia, CA 91355
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D +1.661.567.0667
P +1.888.UTAK.LAB
F +1.661.294.9272
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Book a Meeting with Me
https://calendly.com/ahartmann-utak/30min
utak.com
From: Patti Shugart <pattigaull@aol.com>
Sent: Tuesday, October 7, 2025 10:27 AM
To: Christy Payne <cpayne@carolinachemistries.com>; Andrew Hartmann <ahartmann@utak.com>
Cc: Laura Orlow-Kojac <lorlow@carolinachemistries.com>; Joel Bailey <jbailey@carolinachemistries.com>
Subject: Re: UTAK Control PI Error
Andrew,
Thank you so much, as usual for your prompt attention.
Please let us know how to address the product we have in inventory and in the field.
Do you want a list of customers that received it, so you can send them the updated IFU or how do you want that handled?
Patti