BD Vacutainer Sodium Polyanetholesulfonate 5 — Class II medical device recall Z-0084-2018
Terminated recall by Becton Dickinson & Company, reported 2017-11-15, distributed nationwide. After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes as
| Recall number | Z-0084-2018 |
|---|---|
| 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 | 2017-01-27 |
| Classified | 2017-11-09 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2019-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 90,000 tubes |
| Reason classes | labeling |
| Lot numbers | 6090812 |
| Model numbers | 364960 |
Product
BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960
Reason for recall
After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level.
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-0084-2018. 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.