The Recall Desk
HighFDA (Devices)·Z-1457-2020·Announced 2020-03-18

EHOB Recalls Econocare Plus Waffle Overlay Due to Blood Contamination

EHOB, Inc. is recalling specific lots of Econocare Plus Waffle Overlays due to potential contamination with human blood. No instances of contamination have been confirmed in distributed products.

What this means for you

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: The recall involves a high-risk pathogen (human blood) in a medical device where no illnesses or injuries have been reported, which aligns with the rubric criteria for a High severity score.

Plain-English summary

EHOB, Inc. is recalling specific lots of Econocare Plus Waffle Overlay products. The recall is due to a nonconformance involving product contamination with human blood. The affected products include Master Lot # 932213A and Product Lot Code 932243A. These overlays are intended to aid in the prevention and treatment of pressure injuries and general comfort.

The contamination poses a potential health risk to end users. The firm has distributed these products nationwide within the state of Texas. The company is aware of zero instances of contamination in distributed products that have reached consignees.

Consumers who have these specific products should stop using them and contact EHOB, Inc. for further instructions or a replacement.

The recalled product

Product
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a po
Manufacturer
EHOB, Inc.

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 (2)

  • Master Lot # 932213A
  • Product Lot Code 932243A

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: