Medrad Intego Pet Infusion System, Source Administration Set, Patient Adminstratin Set Model Int Sys 100, Int Css, Int C

• • Ongoing Z-0910-2023 FDA Class II ·initiated 30 Nov 2022

  Black specks may be present on the packaged needles

• • Terminated Z-0400-2017 FDA Class II ·initiated 30 Sep 2016

  The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.

• • Terminated Z-0627-2016 FDA Class II ·initiated 30 Nov 2015

  The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail

510(k) Number

K100798 ↗

FDA Product Code

FRN

Models / Variants

Int Sys 100

Int Css

Int C

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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