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

Stryker Medical Division of Stryker Corporation: Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 350000

Is my product affected?

Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710

  • UPC 07613327282436

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

What happened

Stryker Corporation is recalling three Symmetry Plus Treatment Recliners (Model 3500) that were sold to residential customers instead of being distributed only to healthcare facilities as intended. The recliners were designed for use by healthcare professionals in hospital and medical settings, and their labeling reflects this intended use. Because these devices ended up in home environments, residential users may not be aware of or fully understand the instructions written for trained healthcare professionals.

The recalled units have serial numbers G201170298, G201181816, and G201318385. The recliners were 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 if they own one of these recliners.

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: 3 units Lot/code info: Serial Numbers: G201170298 G201181816 G201318385 UDI: 07613327282436

Source

Official record: FDA (Device enforcement) ↗

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

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