MWT Materials, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0663-2016Class IIAccusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: RadiOctober 6, 2014
Z-0665-2016Class IIAccusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shieldingOctober 6, 2014
Z-0666-2016Class IIAccusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shOctober 6, 2014
Z-0664-2016Class IIAccusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio October 6, 2014
Z-0673-2016Class IIAccusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers October 6, 2014
Z-0671-2016Class IIAccusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: October 6, 2014
Z-0667-2016Class IIAccusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding bOctober 6, 2014
Z-0669-2016Class IIAccusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blOctober 6, 2014
Z-0670-2016Class IIAccusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency October 6, 2014
Z-0672-2016Class IIAccusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers October 6, 2014
Z-0668-2016Class IIAccusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frOctober 6, 2014