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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Dial Oxygen Regulator

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  Class 2 Device Recall Easy Dial Oxygen Regulator see related information
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.
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