FDAClass IIJune 30, 2021

Econocare Plus Waffle Overlay- Intended for use as a recall: Contamination

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…

Why was Econocare Plus Waffle Overlay- Intended for use as a recalled?

Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 105013A

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…
Recalling firm
EHOB, Inc.
Quantity
70 units
Distribution
US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.
Recall date
June 30, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls