Device product
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Z-2221-2021
Product summary
- Event
- Event 88199
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2221-2021
Official wording
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 information: Serial Numbers: F09519 F50699 UDI:07613327169348
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Derived failure modes
-
Unknown
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