Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Other Medical Devices
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Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045
TELEFLEX
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
TELEFLEX
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065
TELEFLEX
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Limacorporate S.p.A
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
TC-I tip clip sensor may produce readings outside the accuracy specification.
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
MEDLINE INDUSTRIES, LP - Northfield
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
TC-I tip clip sensor may produce readings outside the accuracy specification.
TC-I tip clip sensor may produce readings outside the accuracy specification.
Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Olympus Corporation of the Americas
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Karl Storz Endoscopy
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Olympus Corporation of the Americas
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Olympus Corporation of the Americas
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
TC-I tip clip sensor may produce readings outside the accuracy specification.