Medical Park Homecare Recalls Compressed Oxygen Cylinders Due to Gauge Issues
Medical Park Homecare is recalling compressed oxygen cylinders filled using out-of-date gauges. The recall involves M6, D, and E tanks distributed in Oklahoma.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation unlikely to cause adverse health consequences. The issue is a documentation/process deviation (out-of-date gauges) rather than a direct safety hazard like contamination or structural failure.
Plain-English summary
Medical Park Homecare, Inc. is recalling specific lots of Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders). The affected products are packaged in M6-Tanks, D-Tanks, and E-Tanks and are available by prescription only. The recall covers 289 M6-Tank cylinders, 49 D-Tank cylinders, and 743 E-Tank cylinders.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the cylinders were filled using out-of-date gauges. This issue affects the accuracy of the filling process but does not indicate a direct contamination or structural failure of the cylinders themselves.
The affected products were distributed in the United States, including Oklahoma. Consumers and healthcare providers with these specific lot numbers should stop using the cylinders and contact Medical Park Homecare or their healthcare provider for instructions on replacement or return.
The recalled product
- 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.
- Manufacturer
- Medical Park Homecare, Inc
- Category
- Drug — Medical Gas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Lot #'s: 202166
- 202167
- 202168
- 120164
- 120165
- 120166
- 112161
- 112162
- 107161
- 1230151
- 1212151
- 1212152
- 1212153
- 1208154
- 1208155
- 1208156
- 1204152
- 1204153
- 1203151
- 1116156
Distribution
Distributed in 1 state:
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