The Recall Desk
HighFDA (Devices)·Z-2221-2021·Announced 2021-08-18

Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities

Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves pediatric medical equipment distributed outside its intended healthcare facility setting to non-professional users. The device is designed for operation by trained professionals, and home users may not understand the complex instructions, creating a risk-of-harm situation for pediatric patients. Although no injuries have been reported, pediatric equipment in untrained hands inherently presents safety concerns.

Plain-English summary

Stryker Medical Division is recalling the CUB Pediatric Crib, Model FL19, Part #5050000000, a pediatric patient support surface and transport system intended for use in healthcare facilities by trained healthcare professionals.

Two units are affected and have been distributed to the United States, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Affected serial numbers are F09519 and F50699.

The device's labeling correctly identifies it as intended for healthcare facility use. However, the devices were distributed to residential customers and may be in use in home environments where users are not healthcare professionals and may not be aware of or fully understand the complex operating instructions and safety procedures designed for professional healthcare use.

Pediatric medical equipment in untrained hands presents potential safety risks, as improper use, assembly, or operation in non-professional settings could affect patient safety.

The recalled product

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
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Pediatric Crib
Hazard
  • misuse-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: F09519 F50699 UDI:07613327169348

Distribution

Distributed nationwide across the United States.

Related recalls

Same category