FDA Device recall Z-0986-2017
SafeStep¿ Huber Needle Set with Y-Injection Site
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of SafeStep¿ Huber Needle Set with Y-Injection Site by Bard Access Systems, citing bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0986-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-19 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Access Systems |
| Distribution | US |
Product
SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
Reason
Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
Identifiers
| code_info | Lot Number: ASZKS076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0986-2017%22
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