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U.S. Department of Health and Human Services

Class 2 Device Recall Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port

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  Class 2 Device Recall Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port see related information
Date Initiated by Firm March 27, 2018
Date Posted April 17, 2018
Recall Status1 Terminated 3 on May 04, 2021
Recall Number Z-1403-2018
Recall Event ID 79670
Product Classification Connector, airway (extension) - Product Code BZA
Product Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50

Product Usage:
for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Code Information Lot Numbers: 74D1501706 74K1502092 74F1600367 74J1600117 74L1601916 74C1701733 74F1700707 74D1501731 74K1502045 74F1601072 74J1601101 74M1600284 74C1702365 74F1701866 74G1500664 74M1501145 74F1601874 74J1601563 74M1601685 74D1700030 74F1702612 74G1500663 74A1601936 74F1602470 74J1602238 74A1700107 74D1700363 74G1700034 74G1502412 74B1600334 74G1600466 74K1600148 74A1701335 74D1701038 74G1700488 74H1500466 74C1600162 74H1600217 74K1600287 74A1701403 74D1701507 74G1701144 74H1500189 74D1601420 74H1600516 74K1601020 74A1702060 74E1700450 74G1702002 74H1501260 74D1601965 74H1601371 74K1601924 74A1702874 74E1700965 74H1700127 74H1501971 74E1600800 74H1601372 74L1600063 74B1701032 74E1701630 74H1700791 74J1501554 74E1601571 74H1602060 74L1600278 74B1700172 74E1702399 74H1701752 74K1500354 74E1600116 74H1602061 74L1601099 74C1700868 74F1700125 74H1702374  
Recalling Firm/
Manufacturer		 Teleflex Medical Europe Ltd
Ida Business Park
Athlone Ireland
For Additional Information Contact recalls@teleflex.com
866-246-6990
Manufacturer Reason
for Recall		 These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
FDA Determined
Cause 2		 Device Design
Action Teleflex initiated the recall by letter on 03/27/2018. The firm directed the consignee as follows: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot numbers listed above. 2. 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."
Quantity in Commerce 103910 units
Distribution US Nationwide in the states of AU, CA, NZ
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.
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