Recall Z-0009-2020— TELEFLEX-MORRISVILLE

Name: FDA recall Z-0009-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-14

Class I · Terminated

Class I FDA medical device recall by TELEFLEX-MORRISVILLE, initiated 2019-06-14, terminated 2024-06-12. It names one FDA 510(k) clearance: K110383. Product: Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.. Reason: Device vented gas below the stated pressure..

Recalling firm: TELEFLEX-MORRISVILLE
Classification: Class I
Status: Terminated
Initiated: 2019-06-14
Terminated: 2024-06-12
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K110383 — BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical·cleared 2011-08-01

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

Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

Reason for recall

Device vented gas below the stated pressure.

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