TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage
FDA Recall Z-0271-2012 · Posted 2011-11-22
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Recalling FirmEthox International, Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2011-03-25
Date Terminated2011-11-28
Product Quantity130 units
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.
Firm Action
Ethox 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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