Medical equipment, implants, and diagnostic devices
Becton Dickinson & Company
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Compromised sterility due to breach of barrier
Compromised sterility due to breach of barrier
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
Abbott Laboratories
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Compromised sterility due to breach of barrier
Skytron, Div. The KMW Group
The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.
Windstone Medical Packaging
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Integra LifeSciences
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
Covidien
Compromised sterility due to breach of barrier
Compromised sterility due to breach of barrier
Fujifilm Medical Systems U.S.A.
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.