FDA-Device2019-11-13Class I

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

TELEFLEX-MORRISVILLE
Hazard

Device vented gas below the stated pressure.

Sold states
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
Affected count
9,312 each
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2020

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