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
Check against the official notice below — it lists the full affected range.
Stryker Corporation's CUB Pediatric Crib, a medical device designed to provide pediatric patient support and transport in healthcare facilities, was distributed to residential customers who may be using it in home environments. Although the product's labeling correctly identifies that it is intended for use in healthcare facilities, home users may not be aware of or fully understand the instructions that were written for healthcare professionals.
Two units of this product with serial numbers F09519 and F50699 were distributed worldwide, including across the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. Quantity: 2 units Lot/code info: Serial Numbers: F09519 F50699 UDI:07613327169348
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.