ICU Medical de Mexico, S.A. de C.V.

FDA Regulatory Profile

Summary

Total Recalls
20
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2808-2018Class II40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron FilterMarch 1, 2018
Z-2811-2018Class II61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 MicronMarch 1, 2018
Z-2816-2018Class II6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.March 1, 2018
Z-2812-2018Class II10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check VMarch 1, 2018
Z-2813-2018Class II10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating LuerMarch 1, 2018
Z-2800-2018Class IIDISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back March 1, 2018
Z-2815-2018Class II10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), March 1, 2018
Z-2799-2018Class II30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer March 1, 2018
Z-2814-2018Class II11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.March 1, 2018
Z-2797-2018Class II20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer March 1, 2018
Z-2804-2018Class II28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.March 1, 2018
Z-2798-2018Class II165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating LueMarch 1, 2018
Z-2806-2018Class IIKit w/3 Ext Sets, 3 Drop-In MicroClave ClearMarch 1, 2018
Z-2802-2018Class II43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron FilterMarch 1, 2018
Z-2810-2018Class II38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-WMarch 1, 2018
Z-2807-2018Class II191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red RingsMarch 1, 2018
Z-2809-2018Class IIPROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (PMarch 1, 2018
Z-2805-2018Class IIPROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red RMarch 1, 2018
Z-2801-2018Class II216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MMarch 1, 2018
Z-2803-2018Class II18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.March 1, 2018