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U.S. Department of Health and Human Services

Class 1 Device Recall SealFlex

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 Class 1 Recall
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Date Posted April 10, 2013
Recall Status1 Terminated on August 02, 2013
Recall Number Z-1058-2013
Recall Event ID 64751
Premarket Notification
510(K) Number
Product Classification Mask, Gas, Anesthetic - Product Code BSJ
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. .
Code Information REF 8-205508-00 Lot Number: 820550800110419.
Recalling Firm/
Engineered Medical Systems,Inc
2055 Executive Drive
Indianapolis, Indiana 46241-4311
For Additional Information Contact Tamara Lefevers
Manufacturer Reason
for Recall
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
FDA Determined
Cause 2
Action Consignees were notified 9/12/2011 with a Medical Device Voluntary Recall letter identifying the product and the problem. Consignees were directed to quarantine, cease further distribution, and destroy the affected product, returning a proof of confirmation/disposal letter, to be submitted for credit. Correspondence should be sent to Tamara Lefevers, Quality Manager, at tlefevers@ engmedsys.com or fax 317-246-5501.
Quantity in Commerce 1500pcs, 75cs {20pcs per cases)
Distribution Distributed in the states of PA, IN, NY, CO, and CA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSJ and Original Applicant = ENGINEERED MEDICAL SYSTEMS