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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

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. .
Recall Number Z-1058-2013
Classification Class I
Code Info REF 8-205508-00 Lot Number: 820550800110419.
Product Distributed Qty 1500pcs, 75cs {20pcs per cases)
Reason For Recall The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Event Detail

Event Id 64751
Product Type Devices
Status Completed
Recalling Firm Engineered Medical Systems,Inc
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of PA, IN, NY, CO, and CA.