FDAClass IIMarch 31, 2021

PLEUR-EVAC Thoracic Catheters recall: Sterility Concern

PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from…

Why was PLEUR-EVAC Thoracic Catheters recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from…
Recalling firm
TELEFLEX MEDICAL INC
Quantity
520 units (US only)
Distribution
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Recall date
March 31, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls