Recall Z-2922-2020— TELEFLEX MEDICAL INC

Class II · Terminated

Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2020-08-07, terminated 2023-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.. Reason: Potential sterility issue.

Recalling firm
TELEFLEX MEDICAL INC
Classification
Class II
Status
Terminated
Initiated
2020-08-07
Terminated
2023-01-14
Firm location
Morrisville, NC, United States

Product description

Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.

Reason for recall

Potential sterility issue

Data sourced from openFDA. This site is unofficial and independent of the FDA.