# FDA recall Z-3080-2017

> **Vyaire Medical** · Class II · device recall initiated 2017-07-18.

## Product

AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R,  Rx ONLY, CAREFUSION    Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.

## Reason for recall

Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.

## Distribution

Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.

## Key facts

- **Recall number:** Z-3080-2017
- **Recalling firm:** Vyaire Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-18
- **Report date:** 2017-09-06
- **Termination date:** 2019-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vernon Hills, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3080-2017

## Citation

> AI Analytics. FDA recall Z-3080-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-3080-2017. Source: US FDA. Licensed CC0.

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