There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Wilson-Cook Medical
Class I - Dangerous
Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Arrow International
Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Arrow International
Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Class I - Dangerous
The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.
Class I - Dangerous
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Potential for the sterile packaging to be compromised
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Class I - Dangerous
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Class I - Dangerous
Curity All Purpose Sponges were not sterilized and distributed