Reported Jul 11, 2012 · Terminated
AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15…
Thayer Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thayer Medical Corporation · 4575 S Palo Verde Rd Ste 337 · Tucson, AZ · 85714-1961
Is this the product you have?
- 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.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published — Lot Number (EU only): 120405 Expiration Date: Not Applicable Serial Number: Not Applicable — 00885403167839UPC Code (individual device): (01) 00885403167839 00209250885403167834UPC Code (case): (01) 50885403167834 Brand Name: AirLife¿ MiniSpacer¿ MDI Dispenser Adapter Description: 15 mm O.D. / I.D. connections US Product Code: CAF FDA 510(k) Number: K955805 - Amount recalled
- 19340
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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