Medical equipment, implants, and diagnostic devices
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. The field correction initiated is to provide the recommend
Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
DePuy Mitek, Inc., a Johnson & Johnson
Fracture of SPIRALOK Anchors post op, requiring patient revision
Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.