Recall Z-1502-2021 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Medela AG Medical Technology
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
| Date | Dec 2, 2020 |
| Status | Terminated |
| Reason | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". |
| Root cause | Process control |
| Action | On 12/01/2020, the firm sent an "Urgent Field Safety Notice" to customers informing them that the human readable shelf life is: 2023-07-24, whereas the barcode printed on the label shows the correct shelf life "2021-07-24." and that there is no risk to patient if the product is used prior to 2021-07-24. Beyond this date the shelf life is expired, and the sterility of these lots cannot be assured. Customers are instructed to: 1) Confirm that they received the Field Safety Notice by completing the Acknowledgement Form and Customer Response Form; 2) Removed from their inventory, put in quarantin |
| Quantity | 6,244 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA,FL,GA, IL, MA, MI, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WV. The country of Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170329 | Basic, Dominant Flex Modela AG, Mar 24, 2017 |