PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.
FDA Recall Z-1298-2021 · Posted None
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Recalling FirmTELEFLEX MEDICAL INC
Recall StatusTerminated
Product CodeGBX
Date Initiated2021-02-12
Date Terminated2026-07-10
Product Quantity520 units (US only)
Reason for Recall
Teleflex is recalling this product due to a lack of assurance of sterility.
Firm Action
The affected customer is instructed to take the following actions:
1. If you have affected stock in inventory, immediately discontinue use and
quarantine the products.
2. Please complete the enclosed Acknowledgement Form as soon as possible
indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email
to [email protected]. A customer service representative will contact you with a
Return Goods Authorization (RGA) number and provide instructions for the return of
products.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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