Z-1298-2021Class II

PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic...

Name: Z-1298-2021 PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic...
Creator: Teleflex Medical Inc
Published: 2021-02-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2021-02-12 / Terminated / root cause: sterility

FDA source

TELEFLEX MEDICAL INC began a recall of PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the... on 2021-02-12. FDA classified it as Class II and gives the reason as "Teleflex is recalling this product due to a lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1298-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-12
Posted: 2021-03-24
Terminated: 2026-07-10
Recalling firm: Teleflex Medical
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.
Product code: GBX Catheter, Irrigation
Reason for recall: Teleflex is recalling this product due to a lack of assurance of sterility.
Root cause tag: sterility
FDA root cause: Under Investigation by 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.
Quantity in commerce: 520 units (US only)
Distribution: US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Product codes and lots: Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1298-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1298-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)