Z-1058-2013 Class I Terminated
FDA device recall Z-1058-2013 was initiated by Engineered Medical Systems,Inc on September 12, 2011 and is designated Class I. Reason for recall: The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. The recall status is terminated (terminated August 2, 2013). Affected quantity: 1500pcs, 75cs {20pcs per cases).
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.