FOOD AND DRUG
ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
December 9, 1998PRODUCT
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. |
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