Naera Hospital Bassinet, Model No. 4402
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 5,915 Naera Hospital Bassinets, Model No. 4402, distributed nationwide and internationally to 15 countries. The mattress air volume may expand at high altitudes, creating an unintended gap between the inflated patient surface and the tub. This condition could allow patients to move out of position or roll over on the mattress. Although the potential severity of harm includes death, no injuries or harm have been reported to date, and the condition has only occurred in high-altitude regions.
Stryker has decided to replace all recalled Naera mattresses in the field. The record does not specify what actions an affected consumer should take to obtain a replacement.
Written by software from the official notice below. Not reviewed by a lawyer.
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.
Reason for recall: It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field. Distribution: Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico. Quantity: 5915 Lot/code info: 2016000600003 2016000600004 2016000600005 2016000600006 2016000600007 2016000600008 2016000600009 2016000600010 2016000600011 2016000600012 2016000600013 2016000600014 2016000600015 2016000600016 2016000600017 2016000600018 2016000600019 2016000600020 2016000600021 2016000600022 2016000600023 2016000600024 2016000600025 2016000600026 2016000600027 2016000600028 2016000600029 2016000600030 2016000600031 2016000600032 2016000600033 2016000600034 2016000600035 2016000600036 2016000600037 2016000600038 2016000600039 2016000600040 2016000600041 2016000600042 2016000600043 2016000600044 2016000600045 2016000600046 2016000600047 2016000600048 2016000600049 2016000600050 2016000600054 2016000600059 2016000600060 2016000600061 2016000600062 2016000600063 2016000600064 2016000600065 2016000600066 2016000600067 2016000600068 2016000600069 2016000600070 2016000600073 2016000600082 2016000600083 2016000600084 2016000600085 2016000600086 2016000600087 2016000600088 2016000600089 2016000600090 2016000600091 2016000600092 2016000600093 2016000600094 2016000600095 2016000600096 2016000600097 2016000600098 2016000600099 2016000600100 2016000600101 2016000600102 2016000600103 2016000600104 2016000600105 2016000600106 2016000600107 2016000600108 2016000600109 2016000600110 2016000600111 2016000600112 2016000600113 2016000600114 2016000600115 2016000600116 2016000600117 2016000600118 2016000600119 2016000600120 2016000600121 2016000600122 2016000600123 2016000600124 2016000600125 2016000600126 20
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.