FDAFDA · Food and drugs·Recall number Z-1058-2013
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
Published April 17, 2013 · Recall initiated: September 12, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Engineered Medical Systems,Inc
- Distributor
- Distributed in the states of PA, IN, NY, CO, and CA.
- Lot
- REF 8-205508-00 Lot Number: 820550800110419.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.