FDA Device

Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22m

Hazard

Adapters may be occluded potentially preventing inhalation

What You Should Do

Remedy

Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04

Products

Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42
Brand
Bio-Med Devices, Inc.
UPC
Lot Numbers: Last 6 digits  01092304, 01092404, 01092804, 01092904, 01093004, 01100504, 01100604, 01100704 01100804, 01101104, 01101204, 01101404 01101504, 02101804, 01101904, 01102004 01102104, 01102204, 01102504, 05102504 01102604, 01102804, 01102904, 01110104 01110204, 01110504, 09111004, 01111104 05111204, 09111604, 01111704, 01111904 01112204, 09112404, 09113004, 09120204

Units Affected

159 cs