# FDA recall Z-0009-2020

> **TELEFLEX-MORRISVILLE** · Class I · device recall initiated 2019-06-14.

## Product

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

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

## Key facts

- **Recall number:** Z-0009-2020
- **Recalling firm:** TELEFLEX-MORRISVILLE
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-14
- **Report date:** 2019-11-13
- **Termination date:** 2024-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2020

## Citation

> AI Analytics. FDA recall Z-0009-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0009-2020. Source: US FDA. Licensed CC0.

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