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U.S. Department of Health and Human Services

Class 2 Device Recall ET20 Anesthesia Extension Tubes

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 Class 2 Device Recall ET20 Anesthesia Extension Tubessee related information
Date Initiated by FirmJanuary 06, 2016
Date PostedFebruary 03, 2016
Recall Status1 Terminated 3 on March 25, 2016
Recall NumberZ-0696-2016
Recall Event ID 73046
510(K)NumberK083687 
Product Classification Set, administration, intravascular - Product Code FPA
ProductET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Code Information Lot Number 1505201
Recalling Firm/
Manufacturer		 Global Healthcare Inc
11350 Old Roswell Rd
Suite 700
Alpharetta GA 30009-2291
For Additional Information ContactGeorge Lamb
770-522-7520
Manufacturer Reason
for Recall		Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGlobal Healthcare sent an "Urgent: DEVICE RECALL" letter dated January 6, 2015 to its Customer by email. The letter described the product, problem and actions to be taken. The customer was instructed to immediately examine its inventory to determine if you have any of the Model ET-20 on hand; if so, immediately discontinue distributing product; and complete and return the Distributor Device Recall Response Form by email. Additionally, if you have further distributed any of the product, immediately contact your accounts; advise them of recall situation and have them return their outstanding recalled stocks to you. Any returned product will be destroyed by the distributor upon receipt of all affected product. If you require further assistance, please call 770-522-7520.
Quantity in Commerce2,000 cases (100 individual units per case)
DistributionUS Distribution to state of: GA only.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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