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U.S. Department of Health and Human Services

Class 2 Device Recall MoblVac Portable Wound Care Pump

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 Class 2 Device Recall MoblVac Portable Wound Care Pumpsee related information
Date Initiated by FirmMay 10, 2010
Date PostedJune 07, 2010
Recall Status1 Terminated 3 on August 19, 2011
Recall NumberZ-1777-2010
Recall Event ID 55638
510(K)NumberK081185 
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
ProductMoblVac 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).
Code Information Serial numbers NPJ0001 through NPJ0348 and NPK0001 through NPK0095.
FEI Number 1419185
Recalling Firm/
Manufacturer		 Ohio Medical Corporation
1111 Lakeside Dr
Gurnee IL 60031
For Additional Information ContactMs. Anita Christ
847-855-6222
Manufacturer 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 2		Other
ActionOhio 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 Commerce375 units
DistributionNationwide and internationally to Qatar and Oman
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = BTA
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