Linet Spol. S.r.o.: Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.

Recall number

Z-1211-2023

Recalling firm

Linet Spol. S.r.o.

Product

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

Status

Open, Classified

Initiated

2023-01-18

Posted

2023-03-04

Terminated

not on file

Reason

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

Root cause

Labeling design

Action

The firm issued "URGENT MEDICAL DEVICE CORRECTION" recall letters dated 1/17/2023 via email on 1/18/2023. The letter explains the issue that an audible clicking sound can be heard when the side rail is raised, but this sound does not indicate the side rail has locked into the raised position. The consignee is to take immediate action to notify caregivers using the Sprint 200 of this potential hazard and proper use for securing a side rail in the raised position. The consignee is informed that Linet will be adding additional safety warning labels located at each side rail latch (2 per side of stretcher), add additional safety warning labels to both side rails (1 per side of stretcher), and that additional training material and an updated copy of the Sprint 200 Emergency Stretcher Instructions for Use and Technical Description manual is available using the QR code in the letter or by following a link to access the materials. The firm's service department will be contacting the consignees to schedule an appointment to perform the corrections. Photos of the additional warning labels are included in the letter. Please contact LINET service department at 877-815-9897 with immediate questions or concerns.

Quantity

335 stretchers (310 US, 25 OUS)

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FPO

Firm FEI

3008058231

Firm city

Zelevcice

Firm state

not on file

Firm country

Czech Republic

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy