TELEFLEX MEDICAL INC: Medical Device Recall in 2021 - (Recall #: Z-1298-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 12, 2021

Date Posted: March 31, 2021

Recall Number: Z-1298-2021

Event ID: 87346

Reason for Recall:

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

Status: Ongoing

Product Quantity: 520 units (US only)

Code Information:

Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)

Distribution Pattern:

US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.

Voluntary or Mandated:

Voluntary: Firm initiated