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Recall Observatory FDA recall evidence

Device product

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

Z-1211-2023

January 18, 2023

Class II

Product summary

Firm
Linet Spol. S.r.o.
Event
Event 91492
Status
Ongoing
Classification
Class II
Quantity
335 stretchers (310 US, 25 OUS)
Official record key
device-enforcement:Z-1211-2023

Official wording

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

Code information: 1ES200-7 - Serial numbers 20220203852, 20220203853, 20220203854, 20220203407, 20220203429, 20220203425, 20220203427, 20220203428, 20220203430, 20220203836, 20220203864, 20220203402, 20220203404, 20220203420, 20220203422, 20220203841, 20220203850, 20220203858, 20220203862, 20220203865; UDI-DI 08592654358467. 1ES210-1 - Serial numbers 20220204642, 20220204649, 20220204654, 20220204666, 20220207624, 20220261655, 20220261670, 20220261671, 20220261672, 20220204637, 20220204638, 20220204639, 20220204641, 20220204646, 20220204651, 20220204656, 20220204657, 20220207626, 20220207630, 20220261659, 20220261660, 20220261650, 20220261661, 20220261662, 20220261663, 20220261664, 20220261665, 20220261666, 20220261667, 20220261668, 20220261669, 20220261676, 20220204665, 20220207622, 20220207631, 20220207634, 20220207637, 20220207638, 20220207641, 20220207642, 20220207644, 20220207645, 20220261648, 20220261649, 20220261651, 20220261656, 20220261673, 20220261674, 20220261677, 20220261678, 20220261679, 20220261680, 20220261681, 20220261682, 20220261683, 20220261657, 20220261675, 20220190550, 20220190552, 20220190554, 20220190548, 20220204648, 20220204662, 20220207621, 20220207623, 20220207628, 20220207632, 20220207636, 20220207643, 20220204643, 20220204647, 20220204650, 20220204652, 20220204653, 20220204655, 20220204658, 20220204659, 20220204661, 20220204663, 20220204664, 20220207616, 20220207617, 20220207618, 20220207619, 20220207620, 20220207627, 20220207629, 20220207633, 20220207639, 20220261654; UDI-DI 08592654356685. 1ES211-1 - Serial numbers 20220210341, 20220190528, 20220190539, 20220190540, 20220190544, 20220190530, 20220190537, 20220190543, 20220207647, 20220207648, 20220207649, 20220207650, 20220207651, 20220207653, 20220207655, 20220207659, 20220207661, 20220207662, 20220207663, 20220207664, 20220207666, 20220207667, 20220207668, 20220207670, 20220210334, 20220212559, 20220212547, 20220212548, 20220212553, 20220210306, 20220210308, 20220210315, 20220210317, 20220210318, 20220210320, 20220210330, 20220210336, 20220210337, 20220212545, 20220212558; UDI-DI 08592654356678.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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