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U.S. Department of Health and Human Services

Class 2 Device Recall MDI Dispenser /Adapter

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  Class 2 Device Recall MDI Dispenser /Adapter see related information
Date Initiated by Firm June 06, 2012
Date Posted July 02, 2012
Recall Status1 Terminated 3 on January 15, 2013
Recall Number Z-1927-2012
Recall Event ID 62283
510(K)Number K955805  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Thayer Medical Corporation
4575 S Palo Verde Rd Ste 337
Tucson AZ 85714-1961
For Additional Information Contact Julia Hanson
520-790-5393 Ext. 2210
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Thayer Medical sent an Urgent Medical Device Recall letter dated June 7, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Customers were also instructed to destroy and/or dispose of the product in a proper manner and certify to Thayer Medical that they have done so by complelting the attached Certificate of Destruction. The Certificate of Destruction should be sent to Thayer Medical via fax or email. If customers prefer to return the product to Thayer Medical they should contact Customer Service at info@thayermedical.com or fax 1-520-790-5854 for instructions. For questions regarding this recall call 520-790-5393, ext 2210.
Quantity in Commerce 19340
Distribution Worldwide Distribution - USA including CA, KY and Europe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAF and Original Applicant = THAYER MEDICAL CORP.
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