Econocare Plus Waffle Overlay Recalled for Bodily Fluid Contamination
EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where contamination presents a potential exposure hazard to vulnerable patients and healthcare workers. No illnesses or injuries have been reported, but biohazard exposure from bodily fluid contamination is a genuine risk.
Plain-English summary
EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay (Product Code 1025ECP, Lot Number 105013A) due to product contamination with trace amounts of dried bodily fluids.
The Econocare Plus Waffle Overlay is a medical device intended to aid in the prevention and treatment of pressure injuries (bed sores) and provide general comfort. Contamination with dried bodily fluids may expose patients and healthcare providers to contaminants.
The affected product was distributed nationwide in Arizona, Indiana, Maine, Nebraska, Ohio, and South Dakota. Patients and healthcare providers should discontinue use of the recalled product and contact EHOB, Inc. for instructions.
The recalled product
- Product
- Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
- Manufacturer
- EHOB, Inc.
- Affected units
- 70
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)
- Lot Number: 105013A
Distribution
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