Recall Z-1778-2010
Ohio Medical Corporation · initiated May 10, 2010
Product
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.
Codes / lots: model 769709, all units
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1778-2010
- Initiated
- May 10, 2010
- Posted by FDA
- June 7, 2010
- Terminated
- August 19, 2011
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 218 bags
- Distribution
- Nationwide and internationally to Qatar and Oman
- Recalling firm
- Ohio Medical Corporation, Gurnee, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1777-2010 | MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides…Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing… | 05/10/2010Terminated |