Class I - Dangerous
The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Orthohelix Surgical Designs
Class I - Dangerous
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Advanced Sterilization Products
Class I - Dangerous
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Siemens Healthcare Diagnostics
Class I - Dangerous
Correlation slope bias and accuracy shift
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Medtronic Inc. Cardiac Rhythm Disease Management
Class I - Dangerous
Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
Medtronic Inc. Cardiac Rhythm Disease Management
Class I - Dangerous
Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.