Z-0009-2020 Class I Terminated

Recalled by TELEFLEX-MORRISVILLE — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
November 13, 2019
Initiation Date
June 14, 2019
Termination Date
June 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,312 each

Product Description

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

Reason for Recall

Device vented gas below the stated pressure.

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

Code Information

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