Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Bard Peripheral Vascular
Class I - Dangerous
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
There is a potential for distal end of catheters to fracture and become detached.
Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Medtronic Perfusion Systems
Class I - Dangerous
Potential for a wire protrusion through the left heart vent catheter tip
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Argon Medical Devices
Class I - Dangerous
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Soft Tissue Biopsy Needles
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.