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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- MWT Materials, Inc.
- Category
- Medical Device — MRI Accessories
- Hazard
- 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
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 →Related recalls
Same manufacturer · MWT Materials, Inc.
See all →- SevereMWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk
FDA (Devices) · 2016-01-27
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- HighMWT Materials Recalls Accusorb MRI Large Torso Wrap Due to Overheating Risk
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