Recall Z-0714-2020 ยท CAH Filter, Bacterial, Breathing-Circuit
Alliance Tech Medical, Inc
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 n
| Date | Oct 6, 2014 |
| Status | Completed |
| Reason | Patients have experienced a bad taste associated with the filters. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043148 | ALL FLOW PULMONARY FUNCTION FILTER Alliance Tech Medical, Inc., Dec 13, 2004 |