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

Recall date

June 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0009-2020

FDA classification

Class I

Brand / firm

TELEFLEX-MORRISVILLE

Sold / distributed

US nationwide distribution. AL, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TX, VA, WA and WY

Why it was recalled

Device vented gas below the stated pressure.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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