Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 15
FDA device recall Z-1146-2017 · posted 2017-02-07 · Terminated
Recall details
- Recalling firm
- Thayer Medical Corporation
- Reason for recall
- The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.
- Action taken
- Thayer Medical sent an Urgent Medical Device Recall letter dated September 30, 2016, to all affected customers. The letter informed customers that Thayer Medical has identified a labeling error on REF 1543A, Thayer MiniSpacer Dual Spray MDI Adapter with Counter Incrementing Actuator and 15mm O.D./I.D. Connections. Customers were informed to complete and return the attached Customer Reply Form by email to info@thayermedical.com or fax to 1-520-790-5854. For questions regarding this recall call 520-790-5393, ext 2210.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 2,550 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-09-29
- Date posted
- 2017-02-07
- Date terminated
- 2017-02-07
- Location
- Tucson, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR (K111570) | Thayer Medical Corporation | 2011-09-29 |