BD Vacutainer LH — Class II medical device recall Z-2308-2019
Terminated recall by Becton Dickinson & Company, reported 2019-08-28, distributed nationwide. False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples col
| Recall number | Z-2308-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2019-06-12 |
| Classified | 2019-08-21 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,436,228,004 total |
| UPC / GTIN / UDI-DI | 30382903680352 |
| Model numbers | 368494 |
Product
BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
Reason for recall
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
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-2308-2019. 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.