Medical Devices Recalls

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.

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.

Non-conforming product label.

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.

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.

During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.

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.

Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.

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.

Possible open seal on top portion of the package. Could cause breach of sterility.

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.

ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.

Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.