FDA recall Z-2922-2020

TELEFLEX MEDICAL INC · Class II · device

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 for recall

Potential sterility issue

Distribution

US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI

Key facts

Status
Terminated
Initiation date
2020-08-07
Report date
2020-09-09
Termination date
2023-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2922-2020