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U.S. Department of Health and Human Services

Class 2 Device Recall MoblVac Nylon Transport Bag

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  Class 2 Device Recall MoblVac Nylon Transport Bag see related information
Date Initiated by Firm May 10, 2010
Date Posted June 07, 2010
Recall Status1 Terminated 3 on August 19, 2011
Recall Number Z-1778-2010
Recall Event ID 55638
510(K)Number K081185  
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
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.
Code Information model 769709, all units
Recalling Firm/
Manufacturer		 Ohio Medical Corporation
1111 Lakeside Dr
Gurnee IL 60031
For Additional Information Contact Ms. 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
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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = BTA and Original Applicant = OHIO MEDICAL CORPORATION
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