FDA Enforcement
Class II
Ongoing
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Recall: Z-2205-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2205-2021
- Event ID
- 88199
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Medical Division of Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- August 18, 2021
- Initiation Date
- May 12, 2021
- Classification Date
- August 6, 2021
- Address
- 3800 E Centre Ave, N/A, Portage, MI, 49002-5826, United States
Description
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
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
Code Info
UDI (DI#): 07613327278187
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Quantity
3 units