Z-1146-2017Class II

Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections...

Name: Z-1146-2017 Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections...
Creator: Thayer Medical Corporation
Published: 2016-09-29
License: https://open.fda.gov/license/

Thayer Medical Corportation / initiated 2016-09-29 / Terminated / root cause: labeling and UDI

FDA source

Thayer Medical Corporation began a recall of 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... on 2016-09-29. FDA classified it as Class II and gives the reason as "The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1146-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Posted: 2017-02-07
Terminated: 2017-02-07
Recalling firm: Thayer Medical Corportation
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
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.
Root cause tag: labeling and UDI
FDA 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 [email protected] or fax to 1-520-790-5854. For questions regarding this recall call 520-790-5393, ext 2210.
Quantity in commerce: 2,550 units
Distribution: Nationwide Distribution
Product codes and lots: 160214, 160301, 160901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-07

Product code CAF

K111570Class IIMinispacer(r) Mdi Adapter with Counter Incrementing ActuatorThayer Medical Corporation / cleared 2011-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)