FDA-Device2013-04-17Class I
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. .
Engineered Medical Systems,Inc
Hazard
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Sold states
Distributed in the states of PA, IN, NY, CO, and CA.
Affected count
1500pcs, 75cs {20pcs per cases)
Manufactured in
2055 Executive Drive, Indianapolis, IN, United States
Products
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. .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief