March 15, 2000Satilla Home Care Recalls Oxygen
Waycross, GA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Satilla Home Care is recalling compressed oxygen
cylinders because of current good manufacturing practice deviations - Use of an
invalidated oxygen analyzer for assays.
The recalled compressed oxygen (USP)
was sold in 165 (M-6) and 650 (E) liter aluminum cylinders and were distributed in
Georgia. This recall affects Lot Numbers 11199901, 12029902, 12089903, 12169904,
12239905, 12319906, 01070087, 01140008, and 01210009.
This Class II recall
was initiated by Satilla Home Care by visit beginning on or about January 31, 2000.
This is the first public notice issued by the FDA. The FDA has stated that the
company has completed all required recall procedures. The firm estimates that about
50% of those cylinders remained in the homes of patients at time of recall initiation.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-241-0
Notice of this product warning was
sent via email to SafeMail
subscribers March 15, 2000.
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