ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Reported: August 18, 2021 Initiated: May 12, 2021 #Z-2212-2021
Product Description
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
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
Details
- Recalling Firm
- Stryker Medical Division of Stryker Corporation
- Units Affected
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 3 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2212-2021.
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