PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 18, 2021 Initiated: May 12, 2021 #Z-2221-2021

Product Description

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

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

Details

Units Affected
2 units
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 2 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2221-2021.