Recall Z-1778-2010 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Ohio Medical Corporation
NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.
| Date | Jun 7, 2010 (initiated May 10, 2010) |
| Status | Terminated |
| Reason | Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use. |
| Root cause | Other |
| Action | Ohio Medical sent Urgent Medical Device Recall letters dated 5/7/10 to the direct accounts on 5/10/10, with follow-up telephone calls on 5/11/10. The accounts were informed of the one report of an explosion of the pump, and were requested to take the pumps out of service and return the pumps to Ohio Medical. The accounts were requested to complete and fax back to Ohio Medical the enclosed acknowledgement form indicating the number of pumps being returned. Any questions were directed to Anita Christ at 847-855-6270. Follow-up letters dated 5/13/10 were sent to the accounts on 5/14/10, provi |
| Quantity | 218 bags |
| Distribution | Nationwide and internationally to Qatar and Oman |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081185 | MOBLVAC W.C. Ohio Medical Corporation, May 2, 2008 |