FDA Device recall Z-0714-2013
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicat…
- FDA Device
- Class II
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class II recall of Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicat… by Medisystems A Nx Stage, citing A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0714-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-20 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medisystems A Nx Stage |
| Distribution | US |
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
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Identifiers
| code_info | Lot: 120719F4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0714-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.