Recall Z-2005-2014— Teleflex Medical

Name: FDA recall Z-2005-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-05

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-06-05, terminated 2015-07-02. It names one FDA 510(k) clearance: K833974. Product: Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor. Reason: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Terminated: 2015-07-02
Firm location: Durham, 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 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

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