PlainRecalls
FDA Devices Moderate Class II Ongoing

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 per

Reported: March 31, 2021 Initiated: February 12, 2021 #Z-1298-2021

Product Description

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.

Reason for Recall

Teleflex is recalling this product due to a lack of assurance of sterility.

Details

Recalling Firm
TELEFLEX MEDICAL INC
Units Affected
520 units (US only)
Distribution
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by TELEFLEX MEDICAL INC. Units affected: 520 units (US only).
Why was this product recalled? ▼
Teleflex is recalling this product due to a lack of assurance of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1298-2021.

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