There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
DeRoyal Industries
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154
T.A.G. MEDICAL PRODUCTS CORPORATION
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Intuitive Surgical
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
TEI Biosciences
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
BD Synapsys Informatics Solution, Catalog Number 444150
Becton Dickinson &
There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
DeRoyal Industries
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
GE Healthcare Finland Oy
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
TEI Biosciences
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
TEI Biosciences
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
TEI Biosciences
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
TEI Biosciences
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
DeRoyal Industries
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.