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Recall Observatory FDA recall evidence

Device 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.

Z-1298-2021

February 12, 2021

Class II

Product summary

Firm
TELEFLEX MEDICAL INC
Event
Event 87346
Status
Terminated
Classification
Class II
Quantity
520 units (US only)
Official record key
device-enforcement:Z-1298-2021

Official wording

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

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of assurance of sterility