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

Stryker Medical Division of Stryker Corporation: S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 300

Is my product affected?

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX

  • UPC 07613327278309

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

What happened

Stryker Corporation is recalling four units of the S3 MedSurg Bed (Model Number 3005) that were distributed to residential customers instead of healthcare facilities where they are intended to be used. The affected beds have serial numbers 120916611, 121016000, 130115957, and 130815166. The devices were distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Although the product's labeling correctly identifies its intended use in healthcare settings, consumers using the beds in home environments may not be aware of or fully understand the instructions that were designed for healthcare professionals.

The recall notice does not specify a remedy or any required action for consumers who may have one of the affected units.

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: 4 units Lot/code info: Serial Numbers: 120916611 121016000 130115957 130815166 UDI: 07613327278309

Source

Official record: FDA (Device enforcement) ↗

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

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