FDA Medical Device Recalls (openFDA)
Ohio Medical Corporation: Care 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.
- Recall number
- Z-0833-2011
- Recalling firm
- Ohio Medical Corporation
- Product
- Care 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.
- Status
- Terminated
- Initiated
- 2010-11-08
- Posted
- 2010-12-29
- Terminated
- 2012-03-16
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Model 758000; Diode only: serial numbers CDF00000001 thru CDG00001052; Screw only: serial numbers CDJ00000745 thru CDK00000667 Diode & replacement screw: serial numbers CDG00001053 thru CDJ00000744
- 510(k) numbers
- ["K062610"]
- PMA numbers
- not on file
- Product code
- BTA
- Firm FEI
- 1419185
- Firm city
- Gurnee
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28