Recall Z-1101-2015— Teleflex Medical

Name: FDA recall Z-1101-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-14

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2015-01-14, terminated 2017-12-04. It names one FDA 510(k) clearance: K833974. Product: AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.. Reason: The packages may contain foreign material (black particles)..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2015-01-14
Terminated: 2017-12-04
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K833974 — AQUAPAK 020 HUMIDIFIER ADAPTERRespiratory Care, Inc.·cleared 1983-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

Reason for recall

The packages may contain foreign material (black particles).

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