Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL

FDA device recall Z-0833-2011 · posted 2010-12-29 · Terminated

Recall details

Recalling firm

Ohio Medical Corporation

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.

Action taken

Ohio 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.

Root cause

Device Design

Status

Terminated

Product code

BTA

Quantity affected

4,183 units

Distribution

Worldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam.

Date initiated

2010-11-08

Date posted

2010-12-29

Date terminated

2012-03-16

Location

Gurnee, IL

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