Other Medical Devices

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Lack of sterility assurance.

Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access

Lack of sterility assurance.

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Lack of sterility assurance.