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

Is my product affected?

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

• UPC 00885403167839
• UPC 50885403167834

Check against the official notice below — it lists the full affected range.

What happened

Thayer Medical Corporation is recalling the AirLife MiniSpacer MDI Dispenser Adapter with 15 mm connections due to a molding defect in the aerosol dispensing pathway that results in incomplete fill. The recall affects 19,340 units distributed worldwide, including in the USA and Europe. In the US, affected lot numbers are 120320 and 120410, while in Europe only lot number 120405 is affected.

The recall notice does not specify a remedy or recommended action for consumers who have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. Distribution: Worldwide Distribution - USA including CA, KY and Europe. Quantity: 19340 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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