Z-1146-2017 Class II Terminated

Recalled by Thayer Medical Corporation — Tucson, AZ

Recall Details

Product Type
Devices
Report Date
February 15, 2017
Initiation Date
September 29, 2016
Termination Date
February 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,550 units

Product Description

Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream

Reason for Recall

The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.

Distribution Pattern

Nationwide Distribution

Code Information

160214, 160301, 160901