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Recall Observatory FDA recall evidence

Device product

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

Z-0009-2020

June 14, 2019

Class I

Product summary

Firm
TELEFLEX-MORRISVILLE
Event
Event 83119
Status
Terminated
Classification
Class I
Quantity
9,312 each
Official record key
device-enforcement:Z-0009-2020

Official wording

Reason: Device vented gas below the stated pressure.

Code information: Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device vented gas below the stated pressure.