Z-0271-2012

TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA ---

Name: Z-0271-2012 TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA ---
Creator: Ethox International, Inc.
Published: 2011-03-25
License: https://open.fda.gov/license/

Salter Labs / initiated 2011-03-25 / Terminated / root cause: manufacturing process

FDA source

Ethox International, Inc. began a recall of TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage on 2011-03-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0271-2012
Status: Terminated
Initiated: 2011-03-25
Posted: 2011-11-22
Terminated: 2011-11-28
Recalling firm: Salter Labs
Product: TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 130 units
Distribution: Nationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.
Product codes and lots: REF 2075, LOT 031123255 [EXP SYMBOL] 2010/10

Product code KNT

K812648Class IIEhtox Gastric Lavage Kit #2050 & #2070Ethox Corp. / cleared 1981-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)