CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report
AirLife(TM) Reduced Heparin Arterial Blood Sampler recalled
Vyaire Medical is recalling AirLife(TM) Reduced Heparin Arterial Blood Sampler, distributed nationwide in the US. The recall was initiated on 18 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3080-2017
- FDA event ID
- 77845
- Recalling firm
- Vyaire Medical, Vernon Hills, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2017
- FDA classified
- 28 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 18 Jul 2017 | Recall initiated by company | |
| 28 Aug 2017 | Classified by FDA | +41 days |
| 6 Sep 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
Nationwide FloridaMassachusettsMichiganMissouriNew MexicoOklahomaVirginiaWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Number 0001047501
Where was it sold?
Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vyaire Medical
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | AirLife Infant Heated Wire Circuit recalled by Vyaire Medical | Vyaire Medical | Device Malfunction | Nationwide |
| Device | CLASS I | AirLife Infant Heated Wire Circuit recalled by Vyaire Medical | Vyaire Medical | Device Malfunction | Nationwide |
| Device | CLASS I | GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical | Vyaire Medical | Other | Nationwide |
| Device | CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide |
| Device | CLASS I | AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled | Vyaire Medical | Mold | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |