TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavag
FDA device recall Z-0271-2012 · posted 2011-11-22 · Terminated
Recall details
- Recalling firm
- Ethox International, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 130 units
- Distribution
- Nationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.
- Date initiated
- 2011-03-25
- Date posted
- 2011-11-22
- Date terminated
- 2011-11-28
- Location
- Buffalo, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EHTOX GASTRIC LAVAGE KIT #2050 & #2070 (K812648) | Ethox Corp. | 1981-09-29 |