Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Class II FDA: Terminated Nucryo Vascular Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during…
Class II FDA: Terminated Siemens Medical Solutions USA, Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class II FDA: Terminated Cook Inc.
Medical Device Nov 27, 2019
Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead…
Class II FDA: Ongoing Teleflex Medical