FDA Recall Terminated

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.

Recall: Z-1403-2018 · Initiated March 27, 2018

Recall

Recall Number
Z-1403-2018
Event Number
79670
Firm
Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland
FEI Number
3007134520
Product Code
BZA
Status
Terminated
Root Cause
Device Design
Initiated
March 27, 2018
Posted
April 17, 2018
Terminated
May 4, 2021

Description

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.

Reason

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.

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 [email protected]. 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 [email protected]. This will allow us to document your receipt of this letter."

Distribution

US Nationwide in the states of AU, CA, NZ

Quantity

103910 units