AirLife — Class II medical device recall Z-3080-2017
Terminated recall by Vyaire Medical, reported 2017-09-06, distributed nationwide. Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly
| Recall number | Z-3080-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Vernon Hills, IL, United States |
| Recall initiated | 2017-07-18 |
| Classified | 2017-08-28 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2019-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 5,400 units |
| Lot numbers | 0001047501, 9025RHTRABG |
| Model numbers | 9025RHTR |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3080-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.