Year

2016 Product Recalls

6,515 product recalls issued in 2016 across CPSC, FDA, and USDA datasets.

6,515 recalls
High RiskFDA
Icu Medical, Inc.
OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (...
Cardiac Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-6...
Surgical Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure T...
Surgical Devices·30 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77 The...
Surgical Devices·0 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Tra...
Surgical Devices·100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT), Item No. 42583-05 The Tra...
Surgical Devices·3,640 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·950 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transduc...
Cardiac Devices·70 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60", DISPOSABLE TRANSDUCER WITH BO...
Surgical Devices·3,480 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DS...
Surgical Devices·295 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disp...
Surgical Devices·10 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Dispo...
Surgical Devices·210 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16 Th...
Surgical Devices·40 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra...
Surgical Devices·90 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 The Transpac Disposable Straight Pressure Transdu...
Surgical Devices·650 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSP...
Surgical Devices·272 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is ...
Surgical Devices·40 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disp...
Surgical Devices·11,100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item ...
Cardiac Devices·70 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Disposable Straight...
Surgical Devices·100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular ...
Surgical Devices·360 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Tran...
Surgical Devices·10 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·30 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascu...
Surgical Devices·140 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpa...
Cardiac Devices·40 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-0...
Surgical Devices·100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-0...
Surgical Devices·4,470 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-...
Surgical Devices·60 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pres...
Surgical Devices·140 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pres...
Surgical Devices·1,320 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·220 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODR...
Surgical Devices·2,200 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an e...
Surgical Devices·380 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transduc...
Cardiac Devices·100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pr...
Surgical Devices·3,060 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT)...
Surgical Devices·325 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straig...
Surgical Devices·260 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·640 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·135 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Dispo...
Surgical Devices·10 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pres...
Surgical Devices·25 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (...
Cardiac Devices·560 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE ...
Surgical Devices·3,020 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No...
Surgical Devices·260 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular...
Surgical Devices·80 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight ...
Surgical Devices·430 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transd...
Cardiac Devices·120 affected·Sep 27, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and ...
Medical Devices·305 affected·Sep 27, 2016