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U.S. Department of Health and Human Services

Class 1 Device Recall HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port

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  Class 1 Device Recall HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port see related information
Date Initiated by Firm December 13, 2019
Create Date February 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-1113-2020
Recall Event ID 84588
510(K)Number K162242  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
Code Information GTIN 14026704659378 Lot Numbers: 74J1500186 74L1502160 74M1500351 74A1600591 74A1601240 74A1602237 74C1601017 74C1602179 74D1600258 74D1601234 74D1601806 74E1600055 74G1600015 74H1600056 74J1601477 74J1602933 74K1602258 74L1600988 74M1600529 74B1701595 74C1700695 74E1702180 74F1700032 74G1700703 74G1700591 74G1700804 74H1701221 74J1700696 74J1700697 74J1700698 74K1700304 74K1702510 74A1802332 74A1802413 74B1801277 74C1800029 74C1800491 74C1800455 74C1801364 74C1801891 74D1800076 74E1800783 74E1800782 74F1800029 74G1800017 74H1801292 74J1800059 74K1800024 74L1800063 74L1802366 74M1800652 74A1901353 74A1901830 74B1900649 74C1900439 74D1900088 74D1900181 
Recalling Firm/
Manufacturer
TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm initiated the recall by letter on 12/13/2019. The firm is seeking the return of the product. The firm requested the following actions be taken: "1. If you have affected stock, immediately identify all patients that are currently exposed to use of this product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 60467 devices
Distribution nationwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BTT and Original Applicant = TELEFLEX MEDICAL, INC
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