FDA Recall Terminated

Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.

Recall: Z-2922-2020 · Initiated August 7, 2020

Recall

Recall Number
Z-2922-2020
Event Number
86200
Firm
TELEFLEX MEDICAL INC
FEI Number
3005747797
Product Code
GBX
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
August 7, 2020
Terminated
January 14, 2023
Address
3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

Description

Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.

Reason

Potential sterility issue

Action

Teleflex issued an "Urgent Medical Device Recall" notification on August 7, 2020. It states the following actions to be taken: 1. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product code and lot number listed, so that the affected products can be returned to Teleflex. 2. To return product, complete the Recall Acknowledgement Form and fax it to 1-855- 419-8507, Attn: Customer Service or email to [email protected]. 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 Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. If you have any question please contact locals representative or Customer Service at 1-866-396-2111.

Distribution

US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI

Quantity

700 eaches