VACUETTE Safety Blood Collection Set + Luer Adapter — Class II medical device recall Z-0835-2013
Terminated recall by Greiner Bio-One North America, Inc., reported 2013-02-27, distributed nationwide. The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to
| Recall number | Z-0835-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One North America, Inc., Monroe, NC, United States |
| Recall initiated | 2013-02-01 |
| Classified | 2013-02-15 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2013-10-29 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Lot numbers | 12H27 |
| Model numbers | 450096 |
Product
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Reason for recall
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
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-0835-2013. 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.