Z-1058-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2013
- Initiation Date
- September 12, 2011
- Termination Date
- August 2, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1500pcs, 75cs {20pcs per cases)
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.
Distribution Pattern
Distributed in the states of PA, IN, NY, CO, and CA.
Code Information
REF 8-205508-00 Lot Number: 820550800110419.