FDA Device

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 env

Hazard

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.

What You Should Do

Remedy

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.

Products

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) D
Brand
Thayer Medical Corporation
UPC
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

Units Affected

19340