Nipro Safe Touch TULIP Safety Fistula Needle — Class II medical device recall Z-0161-2016
Terminated recall by Nipro Medical Corporation, reported 2015-11-04, distributed in IN. Some 1 1/4" needles were packaged and labeled in the 1" blister package.
| Recall number | Z-0161-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Medical Corporation, Miami, FL, United States |
| Recall initiated | 2015-08-13 |
| Classified | 2015-10-23 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2017-10-13 |
| Distributed | IN |
| Quantity | 50,000 units |
| Reason classes | labeling |
| Lot numbers | 15C03 |
Product
Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
Reason for recall
Some 1 1/4" needles were packaged and labeled in the 1" blister package.
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-0161-2016. 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.