Reported Feb 13, 2019 · Terminated
Naera Hospital Bassinet, Model No. 4402
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?
- Naera Hospital Bassinet, Model No. 4402
- Lot codes and dates
2,174 of 2,174 codes
201600060000320160006000042016000600005201600060000620160006000072016000600008201600060000920160006000102016000600011201600060001220160006000132016000600014201600060001520160006000162016000600017201600060001820160006000192016000600020201600060002120160006000222016000600023201600060002420160006000252016000600026201600060002720160006000282016000600029201600060003020160006000312016000600032201600060003320160006000342016000600035201600060003620160006000372016000600038201600060003920160006000402016000600041201600060004220160006000432016000600044201600060004520160006000462016000600047201600060004820160006000492016000600050201600060005420160006000592016000600060201600060006120160006000622016000600063201600060006420160006000652016000600066201600060006720160006000682016000600069
- Amount recalled
- 5915
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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