Stand, Infusion
General Hospital · 21 CFR 880.6990
Recent MDR events
432 adverse event reports on file
- DRIVE MEDICAL IV POLE, ECON.SV, REM.2HOOKJul 14, 2026InjuryJiangsu Jumao X-care Medical Equipment Co. Ltd.2438477-2026-00046
- PRESSURE MONITORING ACCESSORYMar 23, 2026MalfunctionEdwards Lifesciences Dr2015691-2026-13422
- IV POLEFeb 2, 2026InjuryUnknownMW5183178
- NOV - NOVUM IQJan 7, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-00109
- TABLE, VTS, 120VACSep 30, 2025MalfunctionWells Johnson Co.2024022-2025-00008
- PORT ACCESS DRESSING, SENTRINEX 3D PORT DRESSING (STAND ALONE)Jun 3, 2025MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2025-03584
- IV POLE 4 HOOKS 5 POINT 22" W/ CASTERSApr 16, 2025InjuryUnkMW5169102
- STATLOCK MULTI-PURPOSE 5IN TRICOTJun 25, 2024MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2024-03243
- EKOS¿ CU 4-0 CARTJun 18, 2024MalfunctionBoston Scientific Corporation19556920
- STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREPMay 6, 2024InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2024-02182
Event type breakdown
Recalls
5 recall events for this product code
- Firefly Medical, Inc.TerminatedSep 7, 2017
IVEA Product Part Number 16100 Model 500A
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Z-3239-2017 · View FDA record ↗ - Firefly Medical, Inc.TerminatedDec 15, 2016
IVEA 500A
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
Z-0767-2017 · View FDA record ↗ - EKOS CorporationTerminatedSep 27, 2016
The EKOS cart has the catalog number 700-60101.
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Z-2890-2016 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationTerminatedUnknown
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intend
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached
Z-0344-2016 · View FDA record ↗ - Ohmeda MedicalTerminatedUnknown
Rotating IV Pole
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
Z-1181-2018 · View FDA record ↗
Registered firms
295 firms currently registered for this product code
Yi Yi Transworld Corp.
Taichung City, TW
Hebei Webian Medical Instrument Trading Co., Ltd
SHIJIAZHUANG CITY Hebei, CN
Aht Enterprise Corporation
Hsinchu, TW
Industrias Metalicas Los Pinos Sa
ITAGUI Antioquia, CO
Proactive Medical Products
Mount Vernon, NY, US
Drive Devilbiss Healthcare
Perris, CA, US
Batrik Medical Manufacturing Inc.
Lachine Quebec, CA
Spectros Medical Devices Inc
Houston, TX, US
Bd Switzerland Sarl
Eysins Vaud, CH
Liebel-flarsheim Company Llc
Cincinnati, OH, US
Smeed Technologies Llc
Cumming, GA, US
Ferno Slovakia S.r.o.
Slovak Republic Trenciansky, SK
Microaire Surgical Instruments Llc
CHARLOTTESVILLE, VA, US
Novum Medical Products
AMHERST, NY, US
Foshan Huafukang Medical Technology Co. Ltd
Foshan City Guangdong, CN
Macrolux Medical Technology Co., Ltd.
Shenzhen Guangdong, CN
Golden Season Pte Ltd
SINGAPORE North West, SG
Expeditors
Mississauga Ontario, CA
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Genemax Medical Products Industry Corp.
TAICHUNG CITY, TW
Velocity Concept Development Group, Llc
Cambridge, OH, US
The Surgical Company International B.v.
Amsterdam Noord-Holland, NL
Health Care Logistics, Inc.
Circleville, OH, US
Ready Set Import
Beverly Hills, CA, US
510(k) clearances
36 clearances for this product code
- Clinton Industries, Inc.Apr 6, 1998
K980336 · IV STANDS
- Medrad, Inc.Feb 25, 1997
K964782 · MEDRAD CONTRAST HOLDER
- Prins Medical Ind., Inc.Jul 22, 1996
K961470 · PORT-A-POLE
- Allen Medical Systems, Inc.Mar 12, 1996
K960027 · HIGH VOLUME I.V. & IRRIGATION TOWER
- Valentine Intl. , Ltd.Jul 31, 1995
K952196 · IV POLE/STAND
- Equipment Concepts, Inc.Apr 26, 1995
K950367 · IV SHUTTLE
- Medical Specialties, Inc.Apr 18, 1995
K946201 · STAND, INFUSION
- Hill-Rom, Inc.Mar 17, 1995
K944580 · FLEXSYS MOBILEMATE EQUIPMENT STAND