FDAFDA · Food and drugs·Recall number Z-2211-2021
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
Published August 18, 2021 · Recall initiated: May 12, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- Lot
- Serial Numbers: 111427102713678 UDI:N/A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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