Z-2222-2021 Class II Ongoing
FDA device recall Z-2222-2021 was initiated by Stryker Medical Division of Stryker Corporation on May 12, 2021 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- May 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Code Information
Serial Numbers: FL23J50576 FL23J50577 FL23J60424 FL23J60627 J32346 J32347 J32348 J32350 J29770 UDI: N/A