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Engineered Medical Systems,Inc recalls Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as
Recalled April 17, 2013 · FDA recall Z-1058-2013 · Engineered Medical Systems,Inc
Hazard
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. · FDA Class I
Units
1500pcs, 75cs {20pcs per cases)
Sold at
Distributed in the states of PA, IN, NY, CO, and CA.
Description
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Product
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. .
Manufacturer(s)
Engineered Medical Systems,Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →