Reported Aug 18, 2021 · Ongoing
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860,…
Stryker Medical Division of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Medical Division of Stryker Corporation · 3800 E Centre Ave · Portage, MI · 49002-5826
Is this the product you have?
- IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
- Lot codes and dates
- Serial Numbers031528600216109 051428600212599 081328600206460
- UDI07613327298512
- Amount recalled
- 3 units
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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