Medical Devices Recalls

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.

It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.

Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.

It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.