Stryker Medical Division of Stryker Corporation: IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999

Is my product affected?

IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999

• UPC 07613327298512

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

What happened

Stryker Corporation is recalling 3 units of its IsoGel Air pressure ulcer prevention and treatment support surface (Model Number 2860) because the product was distributed to residential customers for home use, even though it was designed and labeled for use only in healthcare facilities. Home users may not be aware of or fully understand the instructions that were written for healthcare professionals.

The affected units have serial numbers 031528600216109, 051428600212599, and 081328600206460 and 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 remedy consumers should pursue.

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: 031528600216109 051428600212599 081328600206460 UDI: 07613327298512

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 07470000002021-05-12
• Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 08300000002021-05-12
• Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X2021-05-12
• Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 11150000302021-05-12
• Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿2021-05-12

All FDA (Device enforcement) recalls