Econocare Plus Overlay recall: Contamination
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The…
Why was Econocare Plus Overlay recalled?
Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Master Lot # 932213A, Product Lot Code 932243A
- Product
- Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The…
- Recalling firm
- EHOB, Inc.
- Quantity
- U.S. (TX)
- Distribution
- US Nationwide distribution in the state of TX.
- Recall date
- March 18, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)