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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 26, 1998

PRODUCT
Post Type Cylinder Valves, for medical gas cylinders.

Recall #D-134-8.

CODE
All lot codes.

MANUFACTURER
Ceodeux, Inc., Ultrapure Equipment Technology S.A., Lintgen/Luxembourg.

RECALLED BY
Rotarex, Inc., North America, Mt. Pleasant, Pennsylvania, by letter dated March 25, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Massachusetts, Georgia, California, Pennsylvania, Maryland, North Carolina, Kansas, Canada.

QUANTITY
Approximately 125,000 units were manufactured and of that approximately 43,750 remained on market at time of recall initiation.

REASON
High velocity valve stem ejection.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.