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U.S. Department of Health and Human Services

Class 1 Device Recall HUDSON RCI COMFORT FLO Corrugated Humidification System

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  Class 1 Device Recall HUDSON RCI COMFORT FLO Corrugated Humidification System see related information
Date Initiated by Firm December 13, 2019
Create Date February 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-1112-2020
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, REF 2415, humidifier nebulizer kit
Code Information GTIN 14026704659361 Lot Numbers:  74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071 
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 30566 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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