FDA recall Z-1211-2023

Linet Spol. S.r.o. · Class II · device

Product

Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.

Reason for recall

Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.

Distribution

US Distribution was made to AL, CA, FL, IA, KY, LA, MN, NV, NC, OK, TX, VA, WA, and WV. There was no government/military distribution. Foreign distribution was made to Australia, Bahrain, Belgium, Germany, Great Britain, Italy, Netherland, Singapore, South Africa, Switzerland, and United Emirates Canada.

Key facts

Status
Ongoing
Initiation date
2023-01-18
Report date
2023-03-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Zelevcice, Czech Republic

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1211-2023