Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1777-2010

MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the...

Ohio Medical LLC / initiated 2010-05-10 / Terminated

Ohio Medical Corporation began a recall of MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1777-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ohio Medical LLC
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).
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
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 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, 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.
Quantity in commerce
375 units
Distribution
Nationwide and internationally to Qatar and Oman
Product codes and lots
Serial numbers NPJ0001 through NPJ0348 and NPK0001 through NPK0095.