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U.S. Department of Health and Human Services

Class 2 Device Recall Thayer MiniSpacer Dual Spray MDI Adapter

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  Class 2 Device Recall Thayer MiniSpacer Dual Spray MDI Adapter see related information
Date Initiated by Firm September 29, 2016
Date Posted February 07, 2017
Recall Status1 Terminated 3 on February 07, 2017
Recall Number Z-1146-2017
Recall Event ID 75338
510(K)Number K111570  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A.
The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator 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 environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream
Code Information 160214, 160301, 160901
Recalling Firm/
Manufacturer		 Thayer Medical Corporation
4575 S Palo Verde Rd Ste 337
Tucson AZ 85714-1961
For Additional Information Contact Julia Hanson
520-790-5393 Ext. 2210
Manufacturer Reason
for Recall		 The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.
FDA Determined
Cause 2		 Labeling design
Action 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.
Quantity in Commerce 2,550 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAF and Original Applicant = THAYER MEDICAL CORPORATION
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