The Recall Desk

Archive

November 2016 recalls

802 recalls were announced in November 2016.

What the numbers show

Critical
61
Severe
116
High
418
Moderate
173
Low
34

Of the 802 recalls this month scored against our rubric, 8% are Critical, 14% are Severe.

101–200 of 802

  • ModerateFDA (Devices)·Z-0648-2017·2016-11-30

    Beckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags

    Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may cause increased notifications and flags on AQUIOS CL systems, potentially delaying test results.

    Product
    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0641-2017·2016-11-30

    Synthes Recalls 2.5 mm Guide Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile peel pouches are delaminating.

    Product
    2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2017·2016-11-30

    AHP Nifedipine Capsules Recalled for Presence of Foreign Tablets

    Amerisource Health Services is recalling AHP Nifedipine Capsules, 10mg, due to the presence of foreign tablets or capsules in the packaging.

    Product
    AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0151-2017·2016-11-30

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0639-2017·2016-11-30

    Synthes Recalls 3.0 mm Reaming Rods Due to Pouch Delamination

    Synthes (USA) Products LLC is recalling 5,478 sterile 3.0 mm reaming rods because their peel pouches are delaminating.

    Product
    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0147-2017·2016-11-30

    West-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel

    West-Ward Pharmaceuticals is recalling 32,102 bottles of Amoxicillin oral suspension because some bottles are missing the color-coded panel that displays the product strength.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0637-2017·2016-11-30

    Synthes Recalls 2.5 mm Reaming Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 1,951 sterile 2.5 mm reaming rods because their peel pouches are delaminating.

    Product
    2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0148-2017·2016-11-30

    Sun Pharmaceutical Recalls KENALOG Spray Due to Low Alcohol Content

    Sun Pharmaceutical Industries is recalling KENALOG (Triamcinolone Acetonide) Spray due to low alcohol content. The product failed stability specifications.

    Product
    KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0145-2017·2016-11-30

    Sandoz Recalls Ceftriaxone Sodium Vials Due to Missing Labels

    Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection in Wisconsin due to missing labels.

    Product
    CEFTRIAXONE SODIUM — CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·17039·2016-11-29

    Gree Recalls 2.5 Million Dehumidifiers Due to Fire and Burn Hazards

    Gree Electric Appliances is recalling approximately 2.5 million dehumidifiers sold under various brands because they can overheat and catch fire, posing serious fire and burn hazards.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V857000·2016-11-29

    Van Hool Motorcoaches Recalled for Steering Knuckle Carrier Cracking

    Van Hool is recalling specific motorcoaches because front steering knuckle carriers may crack, potentially causing a wheel to separate and increasing crash risk.

    Product
    VAN HOOL — VAN HOOL TD925, C2045, T2140, T2145
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V858000·2016-11-29

    Toyota Recalls 2011-2016 Sienna Minivans for Power Sliding Door Defect

    Toyota is recalling 2011-2016 Sienna minivans because the power sliding door may open unexpectedly while the vehicle is moving, increasing the risk of injury to occupants.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17038·2016-11-29

    Stanley Commercial Door Locksets Recalled Due to Entrapment Risk

    Stanley is recalling about 70,000 commercial door locksets because the latches can fail, preventing doors from being unlocked from the inside during an emergency.

    Product
    Door locksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V860000·2016-11-29

    StarTrans PS2 Transit Buses Recalled for Brake Indicator Malfunction

    Forest River is recalling 2016-2017 StarTrans PS2 buses because the instrument cluster may display 'PARK' instead of 'BRAKE' during a brake malfunction, increasing crash risk.

    Product
    STARTRANS — STARTRANS PS2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V855000·2016-11-28

    Autocar Recalls 2013-2017 Xpeditor Vehicles for Engine Stall Risk

    Autocar is recalling 2013-2017 Xpeditor vehicles because fuse box vibration may cause the ignition relay to open, leading to an engine stall and increased crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V856000·2016-11-28

    Maserati Recalls 2017 Quattroporte and Ghibli for Rear Differential Defect

    Maserati is recalling 326 model year 2017 Quattroporte and Ghibli vehicles because a loose rear differential pinion nut may cause the rear wheels to lock up, increasing crash risk.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V852000·2016-11-28

    Autocar Recalls Xpeditor Vehicles for Hybrid Drive Unit Bolt Defect

    Autocar is recalling 2012-2016 Xpeditor vehicles because hybrid power drive unit bolts may not be tightened properly, risking detachment and crashes.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V854000·2016-11-28

    KTM Recalls 2013-2016 Adventure Motorcycles for Brake Line Melting Risk

    KTM is recalling specific 2013-2016 Adventure and Super Adventure motorcycles because a fraying wiring harness can melt the brake line, potentially causing brake failure.

    Product
    KTM — KTM 1190 ADVENTURE, 1190 ADVENTURE R, 1290 SUPER ADVENTURE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V853000·2016-11-28

    Mercedes-Benz Sprinter Recall for Defective Left Seat Adjusters

    Midwest Automotive Designs is recalling 2016 Mercedes-Benz Sprinter 2500 and 3500 vans because certain left seat adjusters may allow seats to move during a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V851000·2016-11-25

    Gulf Stream Motorhomes Recalled for Improperly Wired In-Dash Radio Assembly

    Gulf Stream is recalling 2016-2017 Conquest and B Touring Cruiser motorhomes because the in-dash radio assembly was improperly wired, allowing the DVD to operate while the vehicle is in motion.

    Product
    GULF STREAM — GULF STREAM B TOURING CRUISER, CONQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·115-2016·2016-11-23

    National Steak and Poultry Recalls Undercooked Ready-to-Eat Chicken

    National Steak and Poultry is recalling approximately 17,439 pounds of ready-to-eat chicken products that may be undercooked, posing a risk of bacterial pathogens.

    Product
    National Steak Processors (2024), LLC. — National Steak and Poultry Recalls Food Service Ready-To-Eat Chicken That May Be Undercooked
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0451-2017·2016-11-23

    C.F. Sauer Recalls Ground Cumin Due to Peanut Contamination

    C.F. Sauer Company is recalling specific lots of ground cumin because the raw ingredient tested positive for peanut protein.

    Product
    SAUER'S GROUND CUMIN,5lbs . CHEF'S MAGIC GROUND CUMIN, 5 lbs. CODE GROUND CUMIN, 5 lbs. JAKE'S GROUND CUMIN,5 lbs. PREMIUM RECIPE GROUND CUMIN,5 lbs RESTAURANT PRIDE GROUND CUMIN,5 lbs.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0449-2017·2016-11-23

    C.F. Sauer Recalls Marcum Chili Powder Due to Peanut Contamination

    C.F. Sauer Company is recalling Marcum Chili Powder because a specific lot of ground cumin seed used in the product tested positive for peanut protein.

    Product
    MARCUM CHILl POWDER, 2.25 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0444-2017·2016-11-23

    C.F. Sauer Recalls Barbeque Spice Due to Peanut Contamination

    C.F. Sauer Company is recalling Sauer's Barbeque Spice because a lot of ground cumin seed used in the product tested positive for peanut protein.

    Product
    SAUER'S BARBEQJ E SPICE, 3 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0448-2017·2016-11-23

    C.F. Sauer Recalls Ground Cumin Due to Peanut Contamination

    C.F. Sauer Company is recalling specific lots of Marcum Ground Cumin because a purchased lot tested positive for peanut protein.

    Product
    MARCUM GROUND CUMIN, 2.25 o z.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0447-2017·2016-11-23

    C.F. Sauer Recalls Multiple Chili Powder Brands Due to Peanut Contamination

    C.F. Sauer Company is recalling multiple brands of 5.5 lb chili powder because a specific lot of ground cumin seed used in the product tested positive for peanut protein.

    Product
    SAUER'S CHILl POWDER, 5.5 lbs. BLUE MOUNTAIN VALLEY CHILl POWDER, 5.5 lbs. CHEF'S MAGIC CHILl POWDER, 5.5 lbs. CODE CHILl POWDER, 5.5 lbs. IFH CHILI POWDER,5.5 lbs. NUGGET CHILl POWDER,5.5 lbs. POCAHONTAS CHILl POWDER, 5.5 lbs. PREMIUM RECIPE CHILl POWDER,
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0453-2017·2016-11-23

    C.F. Sauer Recalls Gold Medal Chili Powder Due to Peanut Contamination

    C.F. Sauer Company is recalling specific lots of Gold Medal Chili Powder and Restaurant Pride Chili Powder because a cumin ingredient tested positive for peanut protein.

    Product
    GOLD MEDAL CHILl POWDER,5.5 lbs RESTAURANT PRIDE DEPENDABLE CHILl POWDER, 5.5 lbs
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0446-2017·2016-11-23

    Sauer's Hot Chili Powder Recalled for Peanut Contamination

    C.F. Sauer Company is recalling Sauer's Hot Chili Powder because a cumin ingredient tested positive for peanut protein.

    Product
    SAUER'S HOT CHILl POWDER, 2.25oz.
    Category
    Food
    Distribution
    0 states
  • SevereUSDA FSIS·114-2016·2016-11-23

    Nick's of Calvert Recalls Meatballs for Undeclared Allergens

    Nick's of Calvert is recalling 305 pounds of meatballs sold in Maryland due to missing production information and undeclared eggs and milk.

    Product
    Nick's of Calvert Recalls Meatball Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0140-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V850000·2016-11-23

    Kalmar Recalls 2014-2016 Ottawa T2 Vehicles for Fire Risk

    Kalmar is recalling 798 model year 2014-2016 Ottawa T2 vehicles because an overloaded ground circuit may increase the risk of a dashboard fire.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0487-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 205 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0476-2017·2016-11-23

    Prime Time International Recalls Cucumbers Due to Salmonella Risk

    Prime Time International is recalling cucumbers because they may be contaminated with Salmonella.

    Product
    PRIME TIME Cucumbers, 1 & 1/9 BUSHEL CARTON, 25kg per carton, TAG ID# 10173318, 10173319, 10173320, 10173322.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0141-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 100 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.

    Product
    CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2017·2016-11-23

    Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 10 units of Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.

    Product
    Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2017·2016-11-23

    ICU Medical Recalls Cardiac Kits with Potential Leak Risk

    ICU Medical is recalling 370 cardiac kits with 0.3 ml flush devices due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy System Software Defect Recall

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to a software defect that causes 2D contour projections to appear off from their true position.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents tha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 660 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard. The affected units were distributed nationwide.

    Product
    Transpac¿ IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves 1 Bonded, Item No. 46104-75 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting cha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curren
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducers and SafeSet Reservoir kits due to a potential for leaks.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 160 units of Transpac IV transducer kits due to a potential leak. The affected products were distributed nationwide.

    Product
    TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2017·2016-11-23

    ICU Medical Recalls Arterial Pressure Kits Due to Leak Risk

    ICU Medical is recalling 380 arterial pressure kits containing Transpac transducers due to a potential leak risk.

    Product
    ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 820 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42641-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer tha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 295 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.

    Product
    Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into elec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 50 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical cur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0430-2017·2016-11-23

    Farm Country Cheese House Recalls White Cheddar Due to Pasteurization Issues

    Farm Country Cheese House is voluntarily recalling White Cheddar cheese blocks because of inadequate pasteurization. The affected product was distributed in Michigan.

    Product
    White Cheddar, thirty-nine, 40 lb. blocks from Vat A and 25 40 lb. blocks from Vat C
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0425-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 520 Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 70 units of Transpac IV transducer kits due to a potential leak. The devices are used for blood sampling and pressure monitoring.

    Product
    MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 3,020 Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 200 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42643-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 75 units of Transpac pressure transducers and SafeSet reservoirs due to a potential leak hazard.

    Product
    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 30 units of Transpac IV Trifurcated Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling specific Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting cha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 80 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 144 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 25 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 260 units of Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 290 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.

    Product
    PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 380 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2017·2016-11-23

    Mevion S250 Proton Therapy Systems Recalled for Isocenter Error Risk

    Mevion Medical Systems is recalling six MEVION S250 proton radiation therapy units because completing setup without a program move can cause an isocenter error.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 740 units of Transpac IV Bifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 130 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling Transpac IV bifurcated monitoring kits because of a potential for leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 950 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into el
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 280 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leak.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42640-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 440 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 90 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into elec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak. The recall covers 1,440 units distributed nationwide.

    Product
    TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting change
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.

    Product
    MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2017·2016-11-23

    Merge PACS software recall due to unviewed image display defect

    Merge Healthcare is recalling Merge PACS software because it may fail to display unviewed images, potentially leading to physician misdiagnosis.

    Product
    Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2017·2016-11-23

    Alphatec Recalls Arsenal Spinal Fixation System Set Screws for Disengagement Risk

    Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.

    Product
    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 125 Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2017·2016-11-23

    ICU Medical Recalls Cath Lab Kits Due to Potential Leak

    ICU Medical is recalling 272 cath lab kits containing SafeSet Reservoirs and Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into elect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 130 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential leak.

    Product
    TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 200 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into el
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 1,320 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Leak Risk

    ICU Medical is recalling 4,580 units of Transpac IV Disposable Transducers with Stopcocks due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 100 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electr
    Category
    Medical Device
    Distribution
    Distributed nationwide

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