Recall Z-0272-2016— Precision Medical, Inc.

Name: FDA recall Z-0272-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-08

Class II · Terminated

Class II FDA medical device recall by Precision Medical, Inc., initiated 2015-10-08, terminated 2016-10-27. It names one FDA 510(k) clearance: K901831. 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.. 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)..

Recalling firm: Precision Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-08
Terminated: 2016-10-27
Firm location: Northampton, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K901831 — PRECISION MEDICAL OXYGEN REGULATORPrecision Medical, Inc.·cleared 1990-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.