FDA Device recall Z-0802-2025
VACUETTE SAFELINK, REF: 450210
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of VACUETTE SAFELINK, REF: 450210 by Greiner Bio One, citing the VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0802-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-19 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Greiner Bio One |
| Distribution | US |
Product
VACUETTE SAFELINK, REF: 450210
Reason
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Identifiers
| code_info | UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0802-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.