Date Initiated by Firm |
September 12, 2011 |
Date Posted |
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
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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
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