FDAFDA · Food and drugs·Recall number Z-0363-2014
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
Published November 27, 2013 · Recall initiated: October 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.
- Lot
- Model FL14E B01008 B05307 B08323 B11351 B14383 B17357 B20142 B23142 B01010 B05308 B08324 B11352 B14384 B17358 B20143 B23143 B01022 B05309 B08325 B11353 B14385 B17358 B20144 B23144 B01045 B05310 B08326 B11354 B14386 B17359 B20145 B23145 B01045 B05311 B08327 B11355 B14387 B17359 B20146 B23146 B01323 B05312 B08328 B11356 B14388 B17360 B20147 B23147 B01356 B05313 B08329 B11357 B14389 B17360 B20148 B23148 B01392 B05314 B08330 B11358 B14390 B17361 B20149 B23149 B01433 B05315 B08331 B11359 B14391 B17361 B20150 B23150 B01434 B05316 B08332 B11360 B14392 B17362 B20151 B23151 B01465 B05317 B08333 B11361 B14393 B17362 B20152 B23152 B01466 B05318 B08334 B11362 B14394 B17363 B20153 B23153 B01467 B05319 B08335 B11363 B14395 B17363 B20154 B23154 B01470 B05320 B08336 B11364 B14396 B17364 B20155 B23155 B01542 B05321 B08337 B11365 B14397 B17364 B20156 B23156 B01597 B05322 B08338 B11366 B14398 B17365 B20157 B23157 B01598 B05323 B08339 B11367 B14399 B17365 B20158 B23158 B01602 B05324 B08340 B11368 B14400 B17366 B20159 B23159 B01729 B05325 B08341 B11369 B14401 B17366 B20160 B23160 B01779 B05326 B08342 B11370 B14402 B17367 B20161 B23161 B01780 B05327 B08343 B11371 B14403 B17367 B20162 B23162 B01781 B05328 B08344 B11372 B14404 B17368 B20163 B23163 B01995 B05329 B08345 B11373 B14405 B17368 B20164 B23164 B01996 B05330 B08346 B11374 B14406 B17369 B20165 B23165 B01997 B05331 B08347 B11375 B14407 B17369 B20166 B23166 B01998 B05332 B08348 B11376 B14408 B17370 B20167 B23167 B01999 B05333 B08349 B11377 B14409 B17370 B20168 B23168 B02000 B05334 B08350 B11378 B14410 B17371 B20169 B23169 B02001 B05335 B08351 B11379 B14411 B17371 B20170 B23170 B02002 B05336 B08352 B11380 B14412 B17372 B20171 B23171 B02013 B05337 B08353 B11381 B14413 B17372 B20172 B23172 B02014 B05338 B08354 B11382 B14414 B17373 B20173 B23173 B02015 B05339 B08355 B11383 B14415 B17373 B20174 B23174 B02016 B05340 B08356 B11384 B14416 B17374 B20175 B23175 B02017 B05341 B08357 B11385 B14417 B17374 B20176 B23176 B02018 B05342 B08358 B11386 B14418 B17375 B20177 B23177 B02019 B05343 B08359 B11387 B14419 B17375 B20178 B23178 B02020 B05344 B08360 B11388 B14420 B17376 B20179 B23179 B02021 B05345 B08361 B11389 B14421 B17376 B20180 B23180 B02022 B05346 B08362 B11390 B14422 B17377 B20181 B23181 B02023 B05347 B08363 B11391 B144222 B17377 B20182 B23182 B02024 B05348 B08364 B11392 B144223 B17378 B20183 B23183 B02025 B05349 B08365 B11393 B144224 B17378 B20184 B23184 B02026 B05350 B08366 B11394 B144225 B17379 B20185 B23185 B02027 B05351 B08367 B11395 B14423 B17379 B20186 B23186 B02028 B05352 B08368 B11396 B14424 B17380 B20187 B23187 B02029 B05353 B08369 B11397 B14425 B17380 B20188 B23188 B02030 B05354 B08370 B11398 B14426 B17381 B20189 B23189 B02031 B05355 B08371 B11399 B14427 B17381 B20190 B23190 B02032 B05356 B08373 B11400 B14428 B17382 B20191 B23191 B02034 B05357 B08374 B11401 B14429 B17382 B20192 B23192 B02035 B05358 B08375 B11402 B14430 B17383 B20193 B23193 B02036 B05359 B08376 B11403 B14431 B17383
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.