Recall Z-2995-2018 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Ohio Medical Corporation
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the
| Date | Sep 7, 2018 (initiated Aug 14, 2018) |
| Status | Terminated |
| Reason | The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Ohio Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 8/7/2018 to its customers on 8/14/2018. The letter described the product, problem and actions to be taken. The customers were instructed to take the affected care-e-vac3 units out of service and follow the instructions, site: https://www.ohiomedical.com/4897450, provided with this notification to change the orientation of the battery; If, upon opening the device, you identify damage to wiring, please contact Ohio Medical Customer Service at 866.549.6446 or email to customer.service@ohiomedical.com f |
| Quantity | 1443 units |
| Distribution | US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062610 | CARE-E-VAC 3 Ohio Medical Corporation, Sep 28, 2006 |