SafeStep¿ Huber Needle Set with Y-Injection Site — Class II medical device recall Z-0986-2017
Terminated recall by Bard Access Systems, reported 2017-01-18, distributed nationwide. Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Sit
| Recall number | Z-0986-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Salt Lake City, UT, United States |
| Recall initiated | 2016-12-19 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 8,000 units |
| Reason classes | labeling |
| Lot numbers | ASZKS076 |
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 for recall
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.
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-0986-2017. 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.