Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code:… — Class II medical device recall Z-0715-2013
Terminated recall by Medisystems a NX Stage Company, reported 2013-01-30, distributed nationwide. Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instea
| Recall number | Z-0715-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medisystems a NX Stage Company, Lawrence, MA, United States |
| Recall initiated | 2012-12-20 |
| Classified | 2013-01-23 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2013-10-10 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 110914F8 |
Product
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
Reason for recall
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
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-0715-2013. 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.