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.
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: 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…
- 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
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