Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anes...
FDA Recall #Z-1058-2013 — Class I — September 12, 2011
Product Description
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. .
Reason for Recall
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Recalling Firm
Engineered Medical Systems,Inc — Indianapolis, IN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1500pcs, 75cs {20pcs per cases)
Distribution
Distributed in the states of PA, IN, NY, CO, and CA.
Code Information
REF 8-205508-00 Lot Number: 820550800110419.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated