Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1778-2010

NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation...

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

Ohio Medical Corporation began a recall of 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 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-1778-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ohio Medical LLC
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.
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
218 bags
Distribution
Nationwide and internationally to Qatar and Oman
Product codes and lots
model 769709, all units