Reported Mar 18, 2020 · Terminated
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general…
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?
- Econocare Plus Overlay Item1025EC. Intended to aid in the prevention and treatment of pressure injuries
- and general comfort - Product UsageThe EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention
- Lot codes and dates
Master Lot # 932213AProduct Lot Code 932243A
- Amount recalled
- U.S. (TX)
Where it was sold
- Nationwide
- TX
Why it was recalled
Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.
This product could cause temporary or reversible health problems — stop using it.
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