Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (incl
Summary
The FDA issued a Class II for Isolibrium Support Surface - support surface assists in the prevention and treat by Stryker Medical Division of Stryker Corporation. Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The prod.
Details
Source
Device Recall
External ID
Z-2215-2021
Action Date
2021-08-18
Status
Ongoing
Category
device
Product Description
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
Lot/Code Info: Serial Numbers: 219009000417 UDI: 07613327278453
Quantity Affected: 1 unit
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-12
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Medical Division of Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Medical Division of Stryker Corporation have FDA actions?
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2215-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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