Class II — Greiner Bio-One North America, Inc.
| Recalling firm | GREINER BIO-ONE NA |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. |
| 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. |
| Quantity | 192,000 pieces (192 cases) |
| Distribution | US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA |
| Initiated | 2013-02-01 |
| Classified | 2013-02-15 |
| Terminated | 2013-10-29 |
| Recall number | Z-0835-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greiner Bio-One North America, Inc. (Z-0835-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64321/
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