OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
FDA recall notice · announced August 15, 2012 · Oklahoma Respiratory Care
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
Reason for recall
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Notes
Distribution: OK
Lot/code information: All lots distributed January 1, 2011 - October 18, 2011.
Quantity: 861 cylinders
Status: Terminated
Products in this recall event:
- OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK (D-1445-2012)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.