FDA Safety Communications – Do Not Use Baby Neck Floats

June 28, 2022

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

The FDA is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy intervention, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury.

The safety communication provides important information about neck floats, including:

  • Details on the potential risk of death or injury in babies
  • Recommendations for parents, caregivers, and health care providers
  • Instructions for reporting problems with a medical device.
Read More

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).

Related Posts

Recall – Vigabatrin for Oral Solution USP

Recall – Vigabatrin for Oral Solution USP

TOPIC: Vigabatrin for Oral Solution USP, 500 mg by InvaGen Pharmaceuticals: Recall - Due to Leaking Sachets AUDIENCE: Patient, Health Professional, Pharmacy, Pediatric, Neurology ISSUE: InvaGen Pharmaceuticals is recalling one lot, NB301030, of Vigabatrin for Oral...

FDA Warns of Rare but Serious Drug Reaction

FDA Warns of Rare but Serious Drug Reaction

The Dup15q Alliance is aware of the recent release by the FDA regarding Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam) warning about the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). This adverse event is...

Medication Recall Alert Sabril® (Vigabatrin)

Medication Recall Alert Sabril® (Vigabatrin)

Our friends at the Epielpsy Foundation have shared the Following Medication Recall The company that makes Sabril® (vigabatrin) for oral solution, a prescription medication to manage seizures in children and adults, has announced a recall of this medication because of...