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CME America, LLC

FDA Regulatory Profile

Summary

Total Recalls
48 (39 Class I)
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0527-2021Class IICME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring cJuly 30, 2020
Z-0525-2021Class IICME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continJuly 30, 2020
Z-0528-2021Class IICME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring coJuly 30, 2020
Z-0526-2021Class IICME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring July 30, 2020
Z-0529-2021Class IICME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fJuly 30, 2020
Z-0530-2021Class IICME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continJuly 30, 2020
Z-2575-2020Class IBodyGuard Microset, REF: A120-003XS2YVJune 16, 2020
Z-2589-2020Class IBodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRVJune 16, 2020
Z-2565-2020Class IBodyGuard Microset, REF: A120-161XPSVJune 16, 2020
Z-2579-2020Class ICMExpress Microbore Sets, REF: A120-160C2YRVJune 16, 2020
Z-2587-2020Class ICMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVKJune 16, 2020
Z-2571-2020Class IBodyGuard Microset with Filter, REF: A120-160XSFEJune 16, 2020
Z-2553-2020Class IBodyGuard BodySet, REF: A120-160SASJune 16, 2020
Z-2582-2020Class IBodyGuard set with Female Luer, REF: A120-003XSNJune 16, 2020
Z-2585-2020Class IStandard BodySet with Needleless Connectors, REF: A120-125XSJune 16, 2020
Z-2586-2020Class ICMExpress Microbore Set, REF: A120-160CJune 16, 2020
Z-2581-2020Class IBodyGuard Microset with Male Luer Connectors, REF: A100-163XEBFJune 16, 2020
Z-2557-2020Class IBodyGuard Microset, REF: A120-161XPSJune 16, 2020
Z-2561-2020Class IBodyGuard Microset, REF: A120-160XYSFJune 16, 2020
Z-2577-2020Class IBodyGuard Microset, REF: A120-160GCFAJune 16, 2020