Morrisville, NC, United States
TELEFLEX-MORRISVILLE recalls
1 recall recorded since 2018, most recently on 14 June 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 14 June 2019
- Terminated
- 12 June 2024
- Reason
- Device vented gas below the stated pressure.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0009-2020
- Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.