September 14, 1999
Heart of the Ozarks Medical Equipment Oxygen
West Plains, MO (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Heart of the Ozarks Medical Equipment is
recalling oxygen, in high-pressure aluminum cylinders, because it contains the incorrect
lot number (bulk) on container and failure to review and approve batch production records
prior to release (current good manufacturing practice deviation).
Oxygen, Rx, USP, in high-pressure aluminum cylinders,
sizes E, AA (M-6) D, and F.
Recall #D-413-9. Class III
Lot numbers: 071699-2 (bulk oxygen lot #563-1959-29) 071699-3 (bulk oxygen lot
Heart of the Ozarks Medical Equipment, West Plains, Missouri.
Manufacturer, by telephone on July 21. 22. Or 27, 1999. Firm-initiated recall
19 cylinders were distributed.
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