Reported Nov 13, 2019 · Terminated

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

Teleflex-Morrisville

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TELEFLEX-MORRISVILLE · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

  • Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Lot codes and dates
  • Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327
Amount recalled
9,312 each

Where it was sold

Why it was recalled

Stop using this product now

Device vented gas below the stated pressure.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 12, 2024 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.