Thayer Medical Corporation: 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

Recall number

Z-1146-2017

Recalling firm

Thayer Medical Corporation

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

Status

Terminated

Initiated

2016-09-29

Posted

2017-02-07

Terminated

2017-02-07

Reason

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

Root cause

Labeling design

Action

Thayer Medical sent an Urgent Medical Device Recall letter dated September 30, 2016, to all affected customers. The letter informed customers that Thayer Medical has identified a labeling error on REF 1543A, Thayer MiniSpacer Dual Spray MDI Adapter with Counter Incrementing Actuator and 15mm O.D./I.D. Connections. Customers were informed to complete and return the attached Customer Reply Form by email to info@thayermedical.com or fax to 1-520-790-5854. For questions regarding this recall call 520-790-5393, ext 2210.

Quantity

2,550 units

Distribution

Nationwide Distribution

Lot, serial or model codes

160214, 160301, 160901

510(k) numbers

["K111570"]

PMA numbers

not on file

Product code

CAF

Firm FEI

2026894

Firm city

Tucson

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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