FDA Enforcement
Class II
Ongoing
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Recall: Z-2220-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2220-2021
- 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
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
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
Serial Numbers: N/A UDI: 07613327282511
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Quantity
1 unit