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U.S. Department of Health and Human Services

Class 2 Device Recall Tpiece Nebulizer with inline connectors

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  Class 2 Device Recall Tpiece Nebulizer with inline connectors see related information
Date Initiated by Firm January 05, 2016
Date Posted February 10, 2016
Recall Status1 Terminated 3 on April 21, 2016
Recall Number Z-0796-2016
Recall Event ID 73130
510(K)Number K884947  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
Code Information Lot No. 083115, 090715, and 122815
Recalling Firm/
Manufacturer		 Salter Labs
2365 Camino Vida Roble
Carlsbad CA 92011-1505
For Additional Information Contact Michael Shoup
760-795-7095
Manufacturer Reason
for Recall		 Reports that the T-piece does not fit on the nebulizer.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A customer letter dated 1/13/16 was sent to all customers who purchased the T-piece Nebulizer with in-line connectors because of reports that the T-piece does not fit on the nebulizer. The letter informs the customers that there has been no reports of interruption or delay in therapy. Customers are instructed to contact Salter Labs Customer Service at 1-800-421-0024 to arrange for the return of the product and replacement inventory. Customers are instructed to acknowledge receipt of the communication by completing the attached reply form and faxing it to the number indicated on the attached form. Customers are instructed to contact Salter Labs Customer Support at 800-421-0024 or your local Salter Labs representative to document any issues that you have encountered or to request replacement inventory.
Quantity in Commerce 70 units
Distribution Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
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 = SALTER LABS
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