FDA WARNING_LETTER - Barkey GmbH & Co. KG - November 04, 2022

The FDA issued a Warning Letter to Barkey GmbH & Co. KG following an inspection from October 31 to November 4, 2022. The firm manufactures the Barkey plasmatherm and Barkey plasmatherm V, devices intended for thawing fresh frozen plasma and warming whole blood/red blood cells.

The primary violation is the introduction of the Barkey plasmatherm V in August 2021 without a new 510(k) premarket notification. This new version includes significant design changes, such as a larger, wire "Smart Motion" paddle and lateral paddle movement, differing from the original's single rubber disc and up-and-down motion. These changes reduce thawing time (e.g., 9 minutes for FFP vs. 14 minutes) and could significantly affect safety or effectiveness, potentially increasing hemolysis risk or impacting plasma clotting factors. Consequently, the Barkey plasmatherm V is adulterated under 21 U.S.C. § 351(f)(1)(B) and misbranded under 21 U.S.C. § 352(o) for failure to submit a required 510(k) (21 CFR 807.81(a)(3)).

Additionally, the firm's devices are adulterated under 21 U.S.C. § 351(h) due to non