Naera Hospital Bassinet, Model No. 4402
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Medical Division of Stryker Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Naera Hospital Bassinet, Model No. 4402
Product Codes/Lot Numbers:
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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0813-2019
Related Recalls
Stryker Arise 1000EX mattress, Part Number 2236000000
Stryker Medical Division of Stryker
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
Stryker MV3 bariatric bed, Part Number 5900000001
Stryker Medical Division of Stryker
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Stryker Medical Division of Stryker
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.