Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing… — Class II medical device recall Z-1146-2017
Terminated recall by Thayer Medical Corporation, reported 2017-02-15, distributed nationwide. The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm
| Recall number | Z-1146-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thayer Medical Corporation, Tucson, AZ, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2017-02-07 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 2,550 units |
| Reason classes | labeling |
| Model numbers | 1543A |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.