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.
Recall
- Recall Number
- Z-1502-2021
- Event Number
- 87551
- Firm
- Medela AG Medical Technology Lattichstrasse 4b Baai Switzerland
- FEI Number
- 3002807523
- Product Code
- BTA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 2, 2020
- Terminated
- June 17, 2024
Description
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.
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
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 quarantine and send back affected lots to their local distributor or confirm that they have destroyed affected lots. 3) Inform any health care professional with their organization that needs to be aware of the Field Safety Notice. For questions or additional assistance - [email protected]
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.
6,244 units