Recall Z-2213-2021— Stryker Medical Division of Stryker Corporation
Class II · Ongoing
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2021-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999. 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 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.
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-05-12
- Firm location
- Portage, MI, United States
Product description
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.