Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code:… — Class II medical device recall Z-0714-2013
Terminated recall by Medisystems a NX Stage Company, reported 2013-01-30, distributed nationwide. A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
| Recall number | Z-0714-2013 |
|---|---|
| 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 | 120719F4 |
Product
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
Reason for recall
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
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-0714-2013. 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.