Z-0272-2016 Class II Terminated

Recalled by Precision Medical, Inc. — Northampton, PA

Recall Details

Product Type
Devices
Report Date
November 25, 2015
Initiation Date
October 8, 2015
Termination Date
October 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
315

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).

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.

Code Information

Lot numbers 072215 and 072315.