AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm
FDA device recall Z-1927-2012 · posted 2012-07-02 · Terminated
Recall details
- Recalling firm
- Thayer Medical Corporation
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 19340
- Distribution
- Worldwide Distribution - USA including CA, KY and Europe.
- Date initiated
- 2012-06-06
- Date posted
- 2012-07-02
- Date terminated
- 2013-01-15
- Location
- Tucson, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL SPRAY MINISPACER (K955805) | Thayer Medical Corp. | 1996-03-21 |