FDA recall Z-2207-2021

Stryker Medical Division of Stryker Corporation · Class II · device

Product

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X

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-2207-2021