International Medsurg Connection, Inc.

FDA Regulatory Profile

Summary

Total Recalls
59
510(k) Clearances
13
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2813-2017Class IIHypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products aJune 23, 2017
Z-2805-2017Class IIHypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The productsJune 23, 2017
Z-2851-2017Class IIPiston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject June 23, 2017
Z-2830-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case June 23, 2017
Z-2854-2017Class IIPiston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject flJune 23, 2017
Z-2856-2017Class IIPiston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used to injectJune 23, 2017
Z-2842-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case June 23, 2017
Z-2862-2017Class IIPiston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to inject fluJune 23, 2017
Z-2822-2017Class IIHypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case The products June 23, 2017
Z-2836-201Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 boxes/case, 2,400/case June 23, 2017
Z-2831-2017Class IIPiston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/case June 23, 2017
Z-2809-2017Class IIHypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The prodJune 23, 2017
Z-2814-2017Class IIHypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products aJune 23, 2017
Z-2844-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/case June 23, 2017
Z-2839-2017Class IIPiston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case June 23, 2017
Z-2812-2017Class IIHypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products aJune 23, 2017
Z-2857-2017Class IIPiston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject flJune 23, 2017
Z-2811-2017Class IIHypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The prodJune 23, 2017
Z-2846-2017Class IIPiston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/case June 23, 2017
Z-2858-2017Class IIPiston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to inject flJune 23, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K110656IMC BLOOD COLLECTION NEEDLEAugust 18, 2011
K110882IMC INSULIN SYRINGEAugust 18, 2011
K102584IMC HYPODERMIC NEEDLEJanuary 14, 2011
K102969IMC PISTON SYRINGESDecember 20, 2010
K100991IMC SURGICAL DRAPEOctober 5, 2010
K100846IMC SURGICAL FACE MASKAugust 16, 2010
K100208IMC SURGICAL DRAPEApril 20, 2010
K052169IMC SURGICAL DRAPESNovember 17, 2005
K042893UNDER BUTTOCKS DRAPEMarch 11, 2005
K023808IRRIGATION SETSMarch 10, 2003
K022159PISTON SYRINGE & HYPODERMIC NEEDLENovember 7, 2002
K014239MEDSURG EQUIPMENT COVERSFebruary 19, 2002
K971159SURGICAL DRAPESJune 24, 1997