Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respirat

FDA device recall Z-1403-2018 · posted 2018-04-17 · Terminated

Recall details

Recalling firm

Teleflex Medical Europe Ltd

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.

Action taken

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."

Root cause

Device Design

Status

Terminated

Product code

BZA

Quantity affected

103910 units

Distribution

US Nationwide in the states of AU, CA, NZ

Date initiated

2018-03-27

Date posted

2018-04-17

Date terminated

2021-05-04

Location

Athlone, Ireland