Recall Z-2215-2021— 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: 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. 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
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
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.