Thayer Medical Corporation: Medical Device Recall in 2017 - (Recall #: Z-1146-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 29, 2016

Date Posted: February 15, 2017

Recall Number: Z-1146-2017

Event ID: 75338

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,550 units

Code Information:

160214, 160301, 160901

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated