|
Class 2 Device Recall Easy Dial Oxygen Regulator |
|
Date Initiated by Firm |
October 08, 2015 |
Date Posted |
November 13, 2015 |
Recall Status1 |
Terminated 3 on October 27, 2016 |
Recall Number |
Z-0272-2016 |
Recall Event ID |
72449 |
510(K)Number |
K901831
|
Product Classification |
Regulator, pressure, gas cylinder - Product Code CAN
|
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. |
Code Information |
Lot numbers 072215 and 072315. |
Recalling Firm/ Manufacturer |
Precision Medical, Inc. 300 Held Dr Northampton PA 18067-1150
|
For Additional Information Contact |
610-262-6090
|
Manufacturer 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).
|
FDA Determined Cause 2 |
Error in labeling |
Action |
The firm sent "Attention Field Corrective Action" letters, dated Oct 8, 2015, to customers. The letter identified the affected device and explained the reason for the recall. The letter provided instructions on how to check the regulator; and asked customers to call the number provided for a replacement if a regulator is labeled incorrectly. |
Quantity in Commerce |
315 |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = CAN and Original Applicant = PRECISION MEDICAL, INC.
|
|
|
|