PLEUR-EVAC Thoracic Catheters — Class II medical device recall Z-1298-2021

Terminated recall by TELEFLEX MEDICAL INC, reported 2021-03-31, distributed nationwide. Teleflex is recalling this product due to a lack of assurance of sterility.

Recall number	`Z-1298-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	TELEFLEX MEDICAL INC, Morrisville, NC, United States
Recall initiated	2021-02-12
Classified	2021-03-24
Reported by FDA	2021-03-31
Terminated	2026-07-10
Distributed	Nationwide (US)
Quantity	520 units
Reason classes	sterility
UPC / GTIN / UDI-DI	`14026704631404`, `34026704631408`
Serial numbers	`73J2000276`
Model numbers	`DRAC-32S`

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1298-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.