CLASS II Device recall · Reported 11 Jul 2012 · FDA Enforcement Report

AirLife¿ MiniSpacer¿ MDI Dispenser Adapter recalled by Thayer Medical

Thayer Medical is recalling AirLife¿ MiniSpacer¿ MDI Dispenser Adapter, distributed in California, Kentucky. The recall was initiated on 6 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPRODUCT CODES Affected Lot Number(s) (US): 120320, 120410 Affected Lot Number (EU only): 120405 Expiration Date: Not Applicable Serial Number: Not Applicable UPC Code (individual device): (01) 00885403167839 UPC Code (case): (01) 50885403167834 Brand Name: AirLife¿ MiniSpacer¿ MDI Dispenser Adapter Description: 15 mm O.D. / I.D. connections Catalogue Number: 002092 US Product Code: CAF FDA 510(k) Number: K955805

Quantity recalled19340

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1927-2012
FDA event ID: 62283
Recalling firm: Thayer Medical, Tucson, AZ
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2012
FDA classified: 2 Jul 2012
Reported: 11 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

6 Jun 2012	Recall initiated by company
2 Jul 2012	Classified by FDA	+26 days
11 Jul 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It 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 MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design 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 it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile.

Where it was distributed

Worldwide Distribution - USA including CA, KY and Europe.

California Kentucky

Questions about this recall

Why was it recalled?

Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.

Which lots are affected?

PRODUCT CODES Affected Lot Number(s) (US): 120320, 120410 Affected Lot Number (EU only): 120405 Expiration Date: Not Applicable Serial Number: Not Applicable UPC Code (individual device): (01) 00885403167839 UPC Code (case): (01) 50885403167834 Brand Name: AirLife¿ MiniSpacer¿ MDI Dispenser Adapter Description: 15 mm O.D. / I.D. connections Catalogue Number: 002092 US Product Code: CAF FDA 510(k) Number: K955805

Where was it sold?

Worldwide Distribution - USA including CA, KY and Europe.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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