NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakesi
FDA device recall Z-1778-2010 · posted 2010-06-07 · Terminated
Recall details
- Recalling firm
- Ohio Medical Corporation
- Reason for recall
- 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.
- Action taken
- 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, providing instructions for the return of the pumps and bags. Shipping boxes will be sent to the accounts based on the number of pumps reported on the acknowledgment form.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTA
- Quantity affected
- 218 bags
- Distribution
- Nationwide and internationally to Qatar and Oman
- Date initiated
- 2010-05-10
- Date posted
- 2010-06-07
- Date terminated
- 2011-08-19
- Location
- Gurnee, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBLVAC W.C. (K081185) | Ohio Medical Corporation | 2008-05-02 |