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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 9, 1998

PRODUCT
Oxygen, USP, Rx, compressed, in aluminum E size high pressure cylinders. Recall #D-031-9.

CODE
The product is labeled under lot number "8202" and transfilled into cylinders that have the following bar codes: 009501, 011796, 012021, 012436, 012711, 014450, 018366, 020073, 020169, 020235, 024281, 024776, 024943, 038376, 038863, 038876, 039018, 039398, 041374, 043517, 044114, 047659, 047848, 047853, 047915, 048325, 050083, 050090, 051270 and 051754.

MANUFACTURER
Tech Air, A Division of Dempsey Enterprises Inc., White Plains, New York.

RECALLED BY
Manufacturer, by telephone on October 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York.

QUANTITY
30 cylinders were distributed; firm estimated that 7 cylinders remained in commerce at time of recall initiation.

REASON
Current good manufacturing practice deviations; including but not limited to failure to maintain production records documenting finished product testing for strength and purity and use of industrial grade oxygen for medical product transfilling.

 

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.