🍔 Food 💊 Drugs 🏥 Medical Devices
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. Class II

Reason: There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio

GE Healthcare, LLC 20131220 Terminated
Distributed: Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Australia, Austria, Azerbaijan, Bahrain, Belgium, BRAZIL, Canada, CHILE, COSTA RICA, Cyprus, Czech Republic, Denmark, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, GUAM, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Kuwait, Lithuania, Malaysia, Malta, Mexico, NEPAL, Netherlands, New Zealand, Norway, Pakistan, PANAMA, PARAGUAY, PERU, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Turkey, United Arab Emirates, United Kingdom, URUGUAY.
View Details
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics. Class II

Reason: The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient

ArjoHuntleigh Inc. 20130911 Terminated
Distributed: US Nationwide and Middle East
View Details
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle. Class II

Reason: CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in

CareFusion 303, Inc. 20140122 Terminated
Distributed: Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
View Details
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision. Class III

Reason: HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.

Horiba Instruments, Inc dba Horiba Medical 20131218 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Canada.
View Details
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position. Class II

Reason: Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

Highland Metals, Inc. 20131213 Terminated
Distributed: Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
View Details
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position. Class II

Reason: Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

Highland Metals, Inc. 20131213 Terminated
Distributed: Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
View Details
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. Class II

Reason: Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

B. Braun Medical, Inc. 20131213 Terminated
Distributed: US Distribution one importer/wholesale distributor in MO.
View Details
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container. Class II

Reason: Bicarbonate Jug Adapter distributed prior to 510(k) approval

Fresenius Medical Care Holdings, Inc. 20131217 Terminated
Distributed: Nationwide Distribution.
View Details
IMPAX RIS QDOC 5.8 Class II

Reason: Patient name displayed (printed) on the Patient Report was the wrong patient name.

AGFA Corp. 20140108 Terminated
Distributed: CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
View Details
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation. Class II

Reason: Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.

Edwards Lifesciences, LLC 20140120 Terminated
Distributed: Nationwide Distribution
View Details
Page 3,637 of 4,030 | Showing 10 recalls
Data provided by openFDA