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FDA (Device enforcement)Recalled 2020-12-02closedclass ii

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 Su

Is my product affected?

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.

  • UPC 07612367052719

Check against the official notice below — it lists the full affected range.

What happened

Medela AG Medical Technology is recalling 6,244 units of Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing due to an incorrect expiration date printed on the product label. The sterile tubing was labeled with an expiration date of July 24, 2023, when the correct expiration date should have been July 24, 2021. The affected tubing is identified by lot number W-024423 and UDI code 07612367052719. This product is used with the Dominant Flex Surgical suction system.

The recalled tubing was distributed worldwide, including U.S. nationwide distribution across 22 states (Arkansas, Arizona, California, Florida, Georgia, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and West Virginia) as well as the Netherlands. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

Details from the source

Reason for recall: Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". 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. Quantity: 6,244 units Lot/code info: Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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