Recall Z-1927-2012 ยท CAF Nebulizer (Direct Patient Interface)
Thayer Medical Corporation
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 breathin
| Date | Jul 2, 2012 (initiated Jun 6, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 p |
| Quantity | 19340 |
| Distribution | Worldwide Distribution - USA including CA, KY and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955805 | DUAL SPRAY MINISPACER Thayer Medical Corp., Mar 21, 1996 |