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U.S. Department of Health and Human Services

Class 2 Device Recall Care E Vac 3 Portable Suction

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 Class 2 Device Recall Care E Vac 3 Portable Suctionsee related information
Date Initiated by FirmNovember 08, 2010
Date PostedDecember 29, 2010
Recall Status1 Terminated 3 on March 16, 2012
Recall NumberZ-0833-2011
Recall Event ID 57196
510(K)NumberK062610 
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
ProductCare E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.
Code Information Model 758000; Diode only: serial numbers CDF00000001 thru CDG00001052;  Screw only: serial numbers CDJ00000745 thru CDK00000667 Diode & replacement screw: serial numbers CDG00001053 thru CDJ00000744
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		The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
FDA Determined
Cause 2		Device Design
ActionOhio Medical sent Urgent Medical Device Correction Notification letters dated November 4, 2010, to all affected customers on November 8, 2010. The letters identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the affected product out of service, remove diode 14, and replace the foot screw contained therein. Customers were instructed to visit the micro-sites established for these repair procedures for step-by-step instructions on performing the repairs. Accounts with questions after viewing the video demonstration were directed to the Ohio Medical technical assistance line at 224-430-1522. Customers were asked to complete the attached Customer Acknowledgment Form and return the form to the Quality Assurance Department at (fax) 1.847.855.6304, or e-mail to: Complaints@OhioMedical.com, or mail to: Ohio Medical Corproation Quality Assurance 1111 Lakeside Drive Gurnee, Illinois 60031. For questions regarding this recall call 847-855-6270.
Quantity in Commerce4,183 units
DistributionWorldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam.
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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