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Today, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to the manufacturer of the SNOO Smart Sleeper (SNOO), Happiest Baby, Inc., for a number of violations, including selling new sleep sack sizes and hospital SNOO bassinet bundles without first undergoing FDA review and obtaining FDA authorization.
The FDA strongly cautions patients, caregivers and health care providers that the X-Small and X-Large sleep sacks, and the SNOO Hospital Bundle, have not been evaluated for safety and effectiveness by the FDA and pose increased risks as described in the Warning Letter. The FDA also cautions that stains, soiling and unsanitary conditions have been reported on refurbished SNOOs distributed to customers, which may pose risk of infection. The FDA also cautions that mold has been reported on SNOO Smart Sleeper mattresses and/or mattress covers.
Questions?
For questions about these products, please contact the Division of Industry and Consumer Education. If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
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