Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
All Recalls
95,083 total recalls in our database
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
W&H DENTALWERK BUERMOOS GMBH
1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
IMPULSE DYNAMICS (USA)
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FUJIFILM Healthcare Americas
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Windstone Medical Packaging
Sterility assurance for saline included in surgical kits cannot be guaranteed.
ESG PK CUTTING FORCEPS, 5MM, 33CM
Olympus Corporation of the Americas
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
3M Company - Health Care Business
3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41ΒΏC (105.8ΒΏF). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60ΒΏC (140ΒΏF) and the Model 9660 blade maximum temperature may reach 77ΒΏC (170.6ΒΏF)."
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Baxter Exactamix Pro 1200, REF EXM12DY
Baxter Healthcare
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
Baxter Exactamix Pro 2400, REF EXM24DY
Baxter Healthcare
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
3M Company - Health Care Business
3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41ΒΏC (105.8ΒΏF). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60ΒΏC (140ΒΏF) and the Model 9660 blade maximum temperature may reach 77ΒΏC (170.6ΒΏF)."