FDA Device recall Z-0813-2019
Naera Hospital Bassinet, Model No. 4402
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of Naera Hospital Bassinet, Model No. 4402 by Stryker Medical Division, citing 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 patie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0813-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-10 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
Product
Naera Hospital Bassinet, Model No. 4402
Reason
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.
Identifiers
| code_info | 2016000600003 2016000600004 2016000600005 2016000600006 2016000600007 2016000600008 2016000600009 2016000600010…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 2016000600 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2019%22
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