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U.S. Department of Health and Human Services

Class 1 Device Recall SealFlex

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 Class 1 Recall
SealFlex
see related information
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
K874746 
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/
Manufacturer
Engineered Medical Systems,Inc
2055 Executive Drive
Indianapolis, Indiana 46241-4311
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Tamara Lefevers
317-246-5500
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
PRODUCTION CONTROLS: Process Control
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
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