FDA-Device2020-06-03Class II
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
Quest Medical, Inc.
Hazard
Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
Sold states
US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
Affected count
5 units
Manufactured in
1 Allentown Pkwy, N/A, Allen, TX, United States
Products
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2020Don't want to check this manually?
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