Thayer Medical product recalled over sterility concerns

Recall date

September 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Thayer Medical Corporation recalls Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1…

Recall number

Z-1146-2017

FDA classification

Class II

Brand / firm

Thayer Medical Corporation

Sold / distributed

Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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