Recall Z-0671-2016— MWT Materials, Inc.

Name: FDA recall Z-0671-2016
Creator: U.S. Food and Drug Administration
Published: 2014-10-06

Class II · Terminated

Class II FDA medical device recall by MWT Materials, Inc., initiated 2014-10-06, terminated 2021-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.. Reason: When not used correctly, Accusorb MRI products may overheat and lead to patient injury..

Recalling firm: MWT Materials, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Terminated: 2021-07-13
Firm location: Passaic, NJ, United States

Product description

Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Reason for recall

When not used correctly, Accusorb MRI products may overheat and lead to patient injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.