Ohio Medical Corporation

The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.

Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: || 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float; || 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float; || 6700-0370-800 - Bottle with Floor Bracket, Cap & Float. || The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.

The bottles have a date stamp on the bottom which consists of a clock dial and a two digit number in the middle with an arrow pointing to the hour number on the dial. The codes 07 -> 5 and 08 ->10 are affected.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.

Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: || 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; || 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; || 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. || The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.

Model 758000; Diode only: serial numbers CDF00000001 thru CDG00001052;  Screw only: serial numbers CDJ00000745 thru CDK00000667 Diode & replacement screw: serial numbers CDG00001053 thru CDJ00000744

General and Plastic Surgery Devices

2

No

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

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.

model 769709, all units

General and Plastic Surgery Devices

2

No

Nationwide and internationally to Qatar and Oman

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.

Serial numbers NPJ0001 through NPJ0348 and NPK0001 through NPK0095.

General and Plastic Surgery Devices

2

No

Nationwide and internationally to Qatar and Oman

MoblVac 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).