Precision Medical Recalls Easy Dial Oxygen Regulators Due to Label Error
Precision Medical is recalling 315 Easy Dial Oxygen Regulators because the settings label may be off by one position, causing incorrect oxygen flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could lead to unintended oxygen delivery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Precision Medical, Inc. is recalling 315 units of Easy Dial Oxygen Regulators, model numbers 168708D and 168715D. The affected units are identified by lot numbers 072215 and 072315. These devices were distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK.
The recall was initiated because the settings label on these regulators could be off by one position. For the 15-liter regulator, when the indicator arrow points to the OFF position, the regulator is actually set to 0.50 liters per minute. For the 8-liter regulator, when the indicator points to OFF, the regulator is actually set to 0.25 liters per minute. This discrepancy means the device may deliver oxygen when the user believes it is turned off.
Consumers who possess these specific model and lot numbers should stop using the devices and contact Precision Medical, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
- Manufacturer
- Precision Medical, Inc.
- Affected units
- 315
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 (1)
- Lot numbers 072215 and 072315.
Distribution
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