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U.S. Department of Health and Human Services

Class 2 Device Recall Sprint 200

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 Class 2 Device Recall Sprint 200see related information
Date Initiated by FirmJanuary 18, 2023
Date PostedMarch 04, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1211-2023
Recall Event ID 91492
Product Classification Stretcher, wheeled - Product Code FPO
ProductSprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
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.
Recalling Firm/
Manufacturer
Linet Spol. S.r.o.
Zelevcice 5
Zelevcice Czech Republic
For Additional Information ContactSteve Krueger
262-894-6427
Manufacturer Reason
for Recall
Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.
FDA Determined
Cause 2
Labeling design
ActionThe 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 Commerce335 stretchers (310 US, 25 OUS)
DistributionUS 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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