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U.S. Department of Health and Human Services

Class 2 Device Recall Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters

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  Class 2 Device Recall Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters see related information
Date Initiated by Firm October 06, 2014
Create Date December 19, 2019
Recall Status1 Completed
Recall Number Z-0714-2020
Recall Event ID 83830
510(K)Number K043148  
Product Classification Filter, bacterial, breathing-circuit - Product Code CAH
Product Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.
Code Information Initial recall - lot number 130905 (all part numbers except 7773100/7773000); second recall - lot number 150102 (part numbers 7773100/7773000 only). 
Recalling Firm/
Manufacturer		 Alliance Tech Medical, Inc
4053 Acton Hwy Ste 103
Granbury TX 76049-6131
For Additional Information Contact Mr. Stuart Campbell
800-848-8923
Manufacturer Reason
for Recall		 Patients have experienced a bad taste associated with the filters.
FDA Determined
Cause 2		 Employee error
Action The first recall was initiated via first class mail on/about 10/6/2014 via an undated letter. The second recall was initiated approximately 8/27/2015 via phone.
Quantity in Commerce Approx. 863/100-unit cases
Distribution Distribution was made to AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, TN, TX, WA, and WY. There was also distribution to Puerto Rico. Foreign distribution was made to Canada.
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.
510(K) Database 510(K)s with Product Code = CAH and Original Applicant = ALLIANCE TECH MEDICAL, INC.
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