Recalls for Adverse Event

G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure
11/14/2015 Medical Recall

If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

  • Category
    Adverse Event
Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection
09/17/2015 Medical Recall

If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.

  • Category
    Adverse Event
Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries
09/02/2015 Medical Recall

If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

  • Category
    Adverse Event
MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures
02/25/2015 Medical Recall

Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.

  • Company:
    INMED
KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use
12/31/2014 Medical Recall

An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.

  • Company:
    Halyard Health
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
12/24/2014 Medical Recall

Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.

  • Company:
    Hospira
10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin
10/31/2014 Medical Recall

Use of this defective Formalin may prevent or delay diagnoses and treatment decisions.

  • Company:
    Emergency Medicine
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter
10/17/2014 Medical Recall

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

  • Company:
    Hospira
LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage
10/15/2014 Medical Recall

A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.

  • Company:
    Stericycle
Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units
10/13/2014 Medical Recall

The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death.

  • Company:
    Philips
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
07/11/2014 Medical Recall

Voluntary Nationwide Recall Of One Lot. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure.

  • Company:
    Hospira Lactated Ringer
Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage
05/23/2014 Medical Recall

Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand.

  • Company:
    Advanced Sterilization Products
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion
05/21/2014 Medical Recall

"Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time.

  • Company:
    Alaris Pump
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory
05/07/2014 Medical Recall

Therapeutic or near therapeutic INR with the test strips but a significantly higher INR when performed by a central laboratory.

  • Company:
    Alere
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up
05/02/2014 Medical Recall

A delay or interruption in therapy has a worst case potential to result in significant injury or death.

  • Company:
    GemStar
Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy
05/02/2014 Medical Recall

Pump may stop the infusion, requiring a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.

  • Company:
    Baxter Healthcare
HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage
04/29/2014 Medical Recall

Failure could result in the pump stopping and lead to serious adverse health consequences, including death.

  • Company:
    HeartWare, Inc.
Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
04/22/2014 Medical Recall

Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates
04/18/2014 Medical Recall

Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy.

  • Company:
    Stericycle
Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products
03/18/2014 Medical Recall

Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention.

  • Company:
    Stericycle
ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off
02/25/2014 Medical Recall

Use of this recalled product may result in serious adverse health consequences.

  • Company:
    ACME Monaco Guidewire
Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure to Deliver Mechanical Breaths
02/20/2014 Medical Recall

Potential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death.

  • Company:
    Philips
Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use
01/22/2014 Medical Recall

Incorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.

  • Company:
    Codman Neuro
t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak
01/14/2014 Medical Recall

Cartridge leak could potentially result in the device delivering too much or too little insulin.

  • Company:
    Tandem Diabetes Care
SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus
01/07/2014 Medical Recall

The fiber filter or the sealing compound, holding the fiber in place, could break apart, exposing patients to bacteria or viruses, which could result in infection or death.

  • Company:
    Nephros Filtration Products
Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter
12/24/2013 Medical Recall

If infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation.

  • Company:
    Stericycle
Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail
11/26/2013 Medical Recall

Potential for a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode.

  • Company:
    Spacelabs Healthcare
CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR)
11/26/2013 Medical Recall

Clinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure.

  • Company:
    CLR Medicals International Inc.
Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift
11/25/2013 Medical Recall

May result in a delay, interruption or over-infusion in therapy, which have a worst case potential to result in significant injury or death depending on the drug and the dosage administered.

  • Company:
    Hospira
New Reliance Traders, Inc. Special Eyeliner: Recall - Elevated Lead Levels
11/16/2013 Medical Recall

Recent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm)

  • Company:
    New Reliance Traders
Medtronic Guidewires: Recall - Potential For Coating On Surface To Delaminate And Detach
11/16/2013 Medical Recall

Some Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.

  • Company:
    Medtronic
Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath Could Remove Particulate
11/06/2013 Medical Recall

Particulate could potentially migrate into a patient’s bloodstream.

  • Company:
    Baylis Medical Company
PENTAX Medical Gas/Water Valves, Model OF-B194: Recall - Manufacturing Defect
11/01/2013 Medical Recall

May prevent users from turning off CO2 gas flow during an endoscopic procedure, leading to risk of peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair.

  • Company:
    PENTAX Medical Company
Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue
10/16/2013 Medical Recall

May result in the inability to access certain menu functions which could possibly lead to delay in treatment.

  • Company:
    GE Healthcare
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue
10/15/2013 Medical Recall

A unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume.

  • Company:
    GE Healthcare
Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final Production Test
10/08/2013 Medical Recall

In extreme cases, may cause a failure of the automatic ventilation function of the device.

  • Company:
    Fabius GS Premium
Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway
10/04/2013 Medical Recall

Defect due to a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping.

  • Company:
    H&H Medical Corporation
Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier
10/02/2013 Medical Recall

Administration of an injectable with the presence of foreign particulates may result in local inflammation, thrombophlebitis, and/or low-level allergic response.

  • Company:
    Hospira
Afikim Electric Vehicles Issues Nationwide Recall Of Breeze C Scooter: Recall - Potential For Malfunction
10/01/2013 Medical Recall

May become unresponsive during operation, resulting in the driver not being able to stop the scooter during operation.

  • Company:
    Afikim Electric Vehicles
HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall - Power, Battery Issues
09/17/2013 Medical Recall

Two separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event.

  • Company:
    HeartSine Technologies
Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter
09/14/2013 Medical Recall

One lot of each strength recalled, administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.

  • Company:
    Bupivacaine HCl
Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I Recall - False Susceptible And False Intermediate Results
09/04/2013 Medical Recall

Defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.

  • Company:
    Siemens
Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin
08/14/2013 Medical Recall

Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.

  • Company:
    Hospira
CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall - Potential Loss of Communication Between Main Processor and Keyboard
08/07/2013 Medical Recall

Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.

  • Company:
    CareFusion
Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance
08/01/2013 Medical Recall

Sterile compounded products distributed nationwide

  • Company:
    Beacon Hill/Rxtra Solutions
LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak
07/24/2013 Medical Recall

Use of this product may cause serious adverse health consequences, including death.

  • Category
    Adverse Event
Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures
06/18/2013 Medical Recall

Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013

  • Company:
    AFX