Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
E3800 PC Units (spare parts)
Radiometer Medical ApS
Class I - Dangerous
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class I - Dangerous
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Class I - Dangerous
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Ossur Americas
Class I - Dangerous
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Circulatory Technology
Class I - Dangerous
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.