Reported Nov 27, 2013 · Terminated
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that…
Stryker Medical Division of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Medical Division of Stryker Corporation · 3800 E Centre Ave · Portage, MI · 49002-5826
Is this the product you have?
- 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
- Lot codes and dates
- Model
4,359 of 4,359 codes
FL14EB01008B05307B08323B11351B14383B17357B20142B23142B01010B05308B08324B11352B14384B17358B20143B23143B01022B05309B08325B11353B14385B17358B20144B23144B01045B05310B08326B11354B14386B17359B20145B23145B01045B05311B08327B11355B14387B17359B20146B23146B01323B05312B08328B11356B14388B17360B20147B23147B01356B05313B08329B11357B14389B17360B20148B23148B01392B05314B08330
- Model
- Amount recalled
- 4126 units USA; 20449 inits Internationally
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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