Home › Device types › FIE
Needle, Fistula
FDA product code FIE · Class 2 · Gastroenterology, Urology
376
Registered devices
761
Adverse events
7
Recalls
80
510(k) clearances
Devices with this code
Medisystems Apheresis Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONJMS A.V. FISTULA NEEDLE SET — JMS SINGAPORE PTE LTDDORA — Bain Medical Equipment (Guangzhou) Co., Ltd.masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS — NXSTAGE MEDICAL, INC.Medisystems Button Hole Needle Set with SteriPick — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with Masterguard Plus — MEDISYSTEMS CORPORATIONmasterguard plus HEMODIALYSIS FISTULA NEEDLE SET — NXSTAGE MEDICAL, INC.Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with Masterguard Plus — MEDISYSTEMS CORPORATIONJMS WINGEATER APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTDMedisystems Hemodialysis Fistula Needle Set with Masterguard Plus — MEDISYSTEMS CORPORATIONJMS WINGEATER A.V.FISTULA NEEDLE SET — JMS SINGAPORE PTE LTDButtonHole with SteriPick TWINPACK+ NEEDLE SET — NXSTAGE MEDICAL, INC.ButtonHole with SteriPick NEEDLE SET — NXSTAGE MEDICAL, INC.DORA — Bain Medical Equipment (Guangzhou) Co., Ltd.Medisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONDORA — Bain Medical Equipment (Guangzhou) Co., Ltd.Medisystems OneSite dual lumen needle with masterguard — MEDISYSTEMS CORPORATIONMedisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus — MEDISYSTEMS CORPORATIONButtonHole with SteriPick TWINPACK+ NEEDLE SET — NXSTAGE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-12-20 | Medisystems a NX Stage Company | Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge |
| 2012-12-20 | Medisystems a NX Stage Company | A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". |
| 2012-01-31 | Medisystems Corp | Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle |
| 2004-12-03 | HK Surgical Inc | Risk of hubs becoming disconnected from the cannula. |
| 2004-12-03 | HK Surgical Inc | Risk of hubs becoming disconnected from the cannula. |
| 2004-12-03 | HK Surgical Inc | Risk of hubs becoming disconnected from the cannula. |
| 2002-11-08 | Nipro Corp | Air or fluid leakage at the hub/needle junction. |
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