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Class 2 Device Recall Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters |
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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
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Product Classification |
Filter, bacterial, breathing-circuit - Product Code CAH
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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.
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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
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For Additional Information Contact |
Mr. Stuart Campbell 800-848-8923
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Manufacturer Reason for Recall |
Patients have experienced a bad taste associated with the filters.
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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
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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.
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510(K) Database |
510(K)s with Product Code = CAH and Original Applicant = ALLIANCE TECH MEDICAL, INC.
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