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

• Date Initiated by Firm: December 13, 2019
• Date Posted: February 07, 2020
• Recall Status: Terminated on April 30, 2024
• Recall Number: Z-1115-2020
• Recall Event ID: 84588
• 510(K)Number: K131912
• Product Classification: Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
• Product: HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
• Code Information: GTIN 14026704659354 Lot Numbers: 74M1400307 74M1400712 74M1401529 74B1500058 74C1501166 74C1502785 74D1500015 74D1501870 74D1500696 74D1501220 74D1502153 74E1500307 74E1500858 74E1500862 74E1501080 74E1501081 74M1500348 74M1500349 74L1502756 74A1601231 74A1602020 74A1602926 74C1601469 74C1601958 74C1600012 74C1601957 74C1602147 74D1600255 74D1600256 74D1601787 74E1600053 74E1601254 74F1600670 74F1602336 74F1603322 74G1600072 74H1600054 74H1600053 74J1600489 74J1602064 74J1603174 74J1602868 74J1602870 74K1601772 74K1602259 74L1600134 74L1601768 74L1602603 74M1601671 74A1701896 74B1700016 74C1700027 74E1700001 74E1700934 74E1702183 74E1701545 74F1702944 74G1700799 74G1701641 74H1700405 74J1700025 74J1701885 74J1702647 74K1700429 74K1702509 74L1700956 74L1702261 74M1700484 74A1801554 74C1800450 74D1800086 74D1801078 74E1800788 74F1801158 74G1800976 74J1800380 74K1800754 74K1800571 74M1800650 74B1900012 74B1900643 74B1902468
• 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: Device Design
• 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: 95696 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 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 = BTT and Original Applicant = TELEFLEX, INC.