Isolibrium Support Surface - support surface assists in recall: Labeling Error
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4…
Why was Isolibrium Support Surface - support surface assists in recalled?
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
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?
Serial Numbers: 219009000417 UDI: 07613327278453
- Product
- Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4…
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Quantity
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)