Recall Z-1777-2010
Ohio Medical Corporation · initiated May 10, 2010
Product
MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case).
Codes / lots: Serial numbers NPJ0001 through NPJ0348 and NPK0001 through NPK0095.
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-1777-2010
- Initiated
- May 10, 2010
- Posted by FDA
- June 7, 2010
- Terminated
- August 19, 2011
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 375 units
- 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-1778-2010 | NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio…Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing… | 05/10/2010Terminated |