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Safety Alerts
September 14, 1999

Heart of the Ozarks Medical Equipment Oxygen Recalled

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 #563-1959-29).

Heart of the Ozarks Medical Equipment, West Plains, Missouri.

Manufacturer, by telephone on July 21. 22. Or 27, 1999. Firm-initiated recall complete.

19 cylinders were distributed.

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