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U.S. Department of Health and Human Services

Class 2 Device Recall Pleurevac

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  Class 2 Device Recall Pleurevac see related information
Date Initiated by Firm August 07, 2020
Create Date August 28, 2020
Recall Status1 Terminated 3 on January 14, 2023
Recall Number Z-2922-2020
Recall Event ID 86200
Product Classification Catheter, irrigation - Product Code GBX
Product 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.
Code Information 74K1900074 74K1901335 74L1901435 74M1900809
Recalling Firm/
Manufacturer		 TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 Potential sterility issue
FDA Determined
Cause 2		 Under Investigation by firm
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 recalls@teleflex.com. 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 recalls@teleflex.com. If you have any question please contact locals representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 700 eaches
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
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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