Class II Recall

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

Summary

The FDA issued a Class II for Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1. by Linet Spol. S.r.o.. Reason: Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury..

Details

Source

Device Recall

External ID

Z-1211-2023

Action Date

2023-03-15

Status

Ongoing

Product Description

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

Lot/Code Info: 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.

Quantity Affected: 335 stretchers (310 US, 25 OUS)

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-01-18

Company

Linet Spol. S.r.o.

Zelevcice

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Linet Spol. S.r.o.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Linet Spol. S.r.o. have FDA actions?

This is the only FDA action we have on record for Linet Spol. S.r.o. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1211-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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