EHOB Expansion Control Overlay Recalled for Potential Blood Contamination
EHOB, Inc. is recalling 173 Expansion Control Overlays (Item No. 1004EC) because a portion of the lot may have been contaminated with blood.
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 potential blood contamination hazard in a medical device, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
EHOB, Inc. is recalling 173 units of the Expansion Control Overlay, Item No. 1004EC, distributed nationwide in the United States. The recall is limited to Lot 93649FA.
The recall was initiated after quality control inspections observed that a portion of the lot may have been contaminated with blood. The product is a medical device designed to assist in lateral transfers, boosts, and turns to protect patients and relieve pressure at bony prominences.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the contamination.
The recalled product
- Product
- Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is…
- Manufacturer
- EHOB, Inc.
- Hazard
- Affected units
- 173
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 93649FA
Distribution
Distributed nationwide across the United States.
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