Recall Z-0833-2011 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Ohio Medical Corporation
Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.
| Date | Dec 29, 2010 (initiated Nov 8, 2010) |
| Status | Terminated |
| Reason | The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened. |
| Root cause | Device Design |
| Action | Ohio Medical sent Urgent Medical Device Correction Notification letters dated November 4, 2010, to all affected customers on November 8, 2010. The letters identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the affected product out of service, remove diode 14, and replace the foot screw contained therein. Customers were instructed to visit the micro-sites established for these repair procedures for step-by-step instructions on performing the repairs. Accounts with questions after viewing the video demonstration were directed to |
| Quantity | 4,183 units |
| Distribution | Worldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062610 | CARE-E-VAC 3 Ohio Medical Corporation, Sep 28, 2006 |