Recall Z-0742-2012 ยท KOJ Airbrush
Groman Inc.
New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece***Pats. Pend. Groman, Inc. Adapater P/N 747 WWW.DisposableAirAbrasion.com 1-800-906-9298. The Cordless Etcher air brush is powered by CO2 mini-cart
| Date | Jan 13, 2012 (initiated Dec 13, 2010) |
| Status | Terminated |
| Reason | Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges. |
| Root cause | Nonconforming Material/Component |
| Action | Groman Inc. sent a "HAZARD NOTICE: IMPORTANT NOTICE ABOUT CORDLESS ETCHER HAZARD DUE TO IMPROPER USE" letter dated March 1, 2011 to all affected customers. The letter describes the product, problem, and advises the customers of the proper use of the device. Customers with questions and concerns, should contact the President of Groman Dental at 800-906-9298 ext. 709. |
| Quantity | 395 |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Rotterdam, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.