FDA Device Intelligence
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Needle, Fistula

FDA product code FIE · Class 2 · Gastroenterology, Urology

379
Registered devices
761
Adverse events
7
Recalls
80
510(k) clearances

Devices with this code

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET — NXSTAGE MEDICAL, INC.Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector — NXSTAGE MEDICAL, INC.Medisystems TwinPack ButtonHole Needle Set with SteriPick — MEDISYSTEMS CORPORATIONJMS A.V. FISTULA NEEDLE SET — JMS SINGAPORE PTE LTDMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONButtonHole with SteriPick TWINPACK+ NEEDLE SET — NXSTAGE MEDICAL, INC.Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONmasterguard plus HEMODIALYSIS FISTULA NEEDLE SET — NXSTAGE MEDICAL, INC.Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems Button Hole Needle Set — MEDISYSTEMS CORPORATIONMedisystems TwinPack ButtonHole Needle Set with SteriPick — MEDISYSTEMS CORPORATIONMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONMedisystems TwinPack ButtonHole Needle Set with SteriPick — MEDISYSTEMS CORPORATIONJMS HARMONY A.V.FISTULA NEEDLE SET — JMS SINGAPORE PTE LTDJMS WINGEATER A.V.FISTULA NEEDLE SET — JMS SINGAPORE PTE LTDNIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER — NIPRO MEDICAL CORPORATIONmasterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS — NXSTAGE MEDICAL, INC.Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONJMS WINGEATER APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTDMedisystems Hemodialysis Fistula Needle Set with MasterGuard — MEDISYSTEMS CORPORATIONmasterguard APHERESIS NEEDLE — NXSTAGE MEDICAL, INC.Medisystems Button Hole Needle Set with SteriPick — MEDISYSTEMS CORPORATIONSUNDER — SUNDER BIOMEDICAL TECH. CO., LTD.NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE — NIPRO MEDICAL CORPORATION

Recent recalls

DateFirmReason
2012-12-20Medisystems a NX Stage CompanySingle needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
2012-12-20Medisystems a NX Stage CompanyA total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
2012-01-31Medisystems CorpMislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle
2004-12-03HK Surgical IncRisk of hubs becoming disconnected from the cannula.
2004-12-03HK Surgical IncRisk of hubs becoming disconnected from the cannula.
2004-12-03HK Surgical IncRisk of hubs becoming disconnected from the cannula.
2002-11-08Nipro CorpAir or fluid leakage at the hub/needle junction.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.