InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 2 units of its InTouch 2131 medical device (Model 2131000000, Part #1460000000) with serial numbers U54274 and U71491. The InTouch 2131 is designed for use in acute care healthcare facility settings, but these particular units were distributed to residential customers and may be in home use. Although the product labeling correctly identifies the proper use environment as a healthcare facility, home users may not be aware of or fully understand these instructions that were intended for healthcare professionals.
The devices were distributed worldwide, including to the United States and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The source document does not specify a remedy or recommended action for consumers who may have received this device.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 2 units Lot/code info: Serial Numbers: U54274 U71491 UDI:07613327169294
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.