Z-1211-2023Class II

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

Name: Z-1211-2023 Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1
Creator: Linet Spol. S.r.o.
Published: 2023-01-18
License: https://open.fda.gov/license/

LINET spol. s r.o. / initiated 2023-01-18 / Open, Classified / root cause: labeling and UDI

FDA source

Linet Spol. S.r.o. began a recall of Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1 on 2023-01-18. FDA classified it as Class II and gives the reason as "Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1211-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-18
Posted: 2023-03-04
Recalling firm: LINET spol. s r.o.
Product: Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Product code: FPO Stretcher, Wheeled
Reason for recall: Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1211-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1211-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-03

Product code FPO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)