• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall SealFlex

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall SealFlex see related information
Date Initiated by Firm September 12, 2011
Date Posting Updated April 10, 2013
Recall Status1 Terminated 3 on August 02, 2013
Recall Number Z-1058-2013
Recall Event ID 64751
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 IN 46241-4311
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
Process change 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSJ and Original Applicant = ENGINEERED MEDICAL SYSTEMS
-
-