All Recalls

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed.

Due to a defect in the outer pouch sterile seal

Procedure Instruments with erroneous unit carton labels.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s).

Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.