Medical Devices Recalls

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

Products labeled as sterile were distributed prior to sterilization

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Potential for software to change the final tool orientation for the command position without command.

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.