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U.S. Department of Health and Human Services

Class 3 Device Recall TUMEVAC

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 Class 3 Device Recall TUMEVACsee related information
Date Initiated by FirmMarch 25, 2011
Date PostedNovember 22, 2011
Recall Status1 Terminated 3 on November 28, 2011
Recall NumberZ-0271-2012
Recall Event ID 60374
510(K)NumberK812648 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductTUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage
Code Information REF 2075, LOT 031123255 [EXP SYMBOL] 2010/10
FEI Number 1314417
Recalling Firm/
Manufacturer		 Ethox International, Inc.
251 Seneca Street
Buffalo NY 14204
For Additional Information ContactSusan Marra
716-842-4000
Manufacturer Reason
for Recall		Ethox Tum-E-Vac Gastric Lavage Kit #2075, Lot Number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton was labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.
FDA Determined
Cause 2		Employee error
ActionEthox International, Inc. sent an "URGENT DEVICE RECALL" letter dated March 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine if they have the affected product. Customers are to return the affected product to the firm by using UPS account 128959. Customers will be reimbursed for the returned goods. Additionally, a response form was enclosed for customers to complete and return. Contact the firm at (716) 842-4000 for questions regarding this recall.
Quantity in Commerce130 units
DistributionNationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.
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 = KNT
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