Reported Jul 29, 2020 · Terminated

Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface,…

EHOB, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: EHOB, Inc. · 250 N Belmont Ave · Indianapolis, IN · 46222-4265

Is this the product you have?

  • Expansion Control Overlay, Item No. 1004EC -
  • Product UsageThe EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable
Lot codes and dates
  • Lot 93649FA
Amount recalled
173

Where it was sold

  • Nationwide

Why it was recalled

QC inspection observed that a portion of the lot may have been contaminated with blood.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 25, 2021 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.