Oxygen recall: CGMP Deviations
Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
Why was Oxygen recalled?
CGMP Deviations: Cylinders filled using out of date gauges.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) Lot #'s: 202166, 202167, 202168, 120164, 120165, 120166, 112161, 112162, 107161, 1230151, 1212151, 1212152, 1212153, 1208154, 1208155, 1208156, 1204152, 1204153, 1203151, 1116156, 1112151, 1112152. b) Lot #'s: 120164, 1212153, 1208154, 1204151, 1116156, 1112151. c) Lot #'s: 202161, 202162, 202163, 202164, 202165, 120161, 120162, 120163, 120164, 119161, 119162, 119163, 112163, 112164, 107162, 107163, 1230152, 1208151, 1208152, 1208153, 1204152, 1203152, 1203153, 1202151, 1202152, 1202153, 1125151, 1125152, 1116151, 1116152, 1116153, 1116154, 1116155, 1116156, 1112151, 1109151, 1109152, 1109153, 1109154, 1109155, 1109156, 1103151, 1103152, 1103153, 1103154, 1102151, 1102152, 1102153, 1102154.
- Product
- Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
- Recalling firm
- Medical Park Homecare, Inc
- Quantity
- a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders.
- Distribution
- U.S. Including: Oklahoma
- Recall date
- March 23, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)