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Terminated

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.

FDA Recall Z-0671-2016 · Posted None

Recalling FirmMWT Materials, Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-10-06
Date Terminated2021-07-13
Product Quantity47 units

Reason for Recall

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

Firm Action

MWT issued a letter dated 10/4/2014 via email to all distributors for further distribution to consignees. Tghe letter identified the affected product, problem and actions to be taken. Questions can be direct to [email protected].

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states of NY and MA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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