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FDA (Device enforcement)Recalled 2021-05-12class ii

Stryker Medical Division of Stryker Corporation: Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000

Is my product affected?

Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000

  • UPC 07613327282511

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling the Stretcher Chair Model 5050 (Part # 5050000000) because one unit intended for use only in healthcare facilities was distributed to a residential customer instead. The product's labeling correctly identifies that it should only be used in acute care hospitals and medical outpatient services, but consumers using it in a home environment may not be aware of or understand these professional healthcare instructions.

The recalled unit was distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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: 1 unit Lot/code info: Serial Numbers: N/A UDI: 07613327282511

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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