The Recall Desk
SevereFDA (Devices)·Z-0671-2016·Announced 2016-01-27

MWT Materials Recalls Accusorb MRI Leg Wrap Blankets Due to Overheating Risk

MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets because they may overheat when not used correctly, posing a risk of patient injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the products may lead to patient injury, which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4 (Severe).

Plain-English summary

MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets (Part Number: MRI-09, MAC7009). These products are radio frequency shielding blankets and body-part covers designed for use in the MRI environment. The recall covers various sizes of the leg wrap blanket.

The recall was initiated because the products may overheat when not used correctly, which could lead to patient injury. The agency has classified this as a Class II recall.

The affected units were distributed nationwide in the United States, specifically in the states of New York and Massachusetts. Healthcare facilities and users should stop using the affected products and contact the recalling firm for instructions on return or replacement.

The recalled product

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.
Affected units
47

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by MWT Materials, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →