Recall Z-1502-2021— Medela AG Medical Technology
Class II · Terminated
Class II FDA medical device recall by Medela AG Medical Technology, initiated 2020-12-02, terminated 2024-06-17. It names one FDA 510(k) clearance: K170329. Product: 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.. Reason: Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24"..
- Recalling firm
- Medela AG Medical Technology
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-02
- Terminated
- 2024-06-17
- Firm location
- Baai, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
Data sourced from openFDA. This site is unofficial and independent of the FDA.