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Recall Observatory FDA recall evidence

Device 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.

Z-0272-2016

October 08, 2015

Class II

Product summary

Firm
Precision Medical, Inc.
Event
Event 72449
Status
Terminated
Classification
Class II
Quantity
315
Official record key
device-enforcement:Z-0272-2016

Official wording

Reason: These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).

Code information: Lot numbers 072215 and 072315.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).