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

Stryker Medical Division of Stryker Corporation: Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Nu

Is my product affected?

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿

  • UPC 07613327506129

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

What happened

Stryker Corporation is recalling the Michael Graves with Stryker Highback Chair, a seating product designed for use in healthcare facilities by medical professionals. One unit with serial number G201179538 was distributed to a residential customer instead of a healthcare setting. Although the product's labeling correctly identifies its intended use in medical facilities, consumers using the chair at home may not be aware of or fully understand the instructions designed for healthcare professionals.

The affected chair was distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The source document does not specify what consumers should do regarding this recall.

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: G201179538 UDI: 07613327506129

Source

Official record: FDA (Device enforcement) ↗

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

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