FDAFDA · Food and drugs·Recall number Z-0009-2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Published November 13, 2019 · Recall initiated: June 14, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Device vented gas below the stated pressure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TELEFLEX-MORRISVILLE
- Distributor
- 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
- Lot
- Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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