FDA recall Z-2212-2021

Stryker Medical Division of Stryker Corporation · Class II · device

Product

ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

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.

Key facts

Status: Ongoing
Initiation date: 2021-05-12
Report date: 2021-08-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2021