Surgical Instruments

Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.

Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.

Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.

Scalpels lot contains non-sterile products labeled as sterile.

The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.

Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The retail shelf cartons may be labeled with an incorrect lot number.

The retail shelf cartons may be labeled with an incorrect lot number.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.