Medela AXS Universal Aspiration Tubing Recalled for Incorrect Expiration Date
Medela is recalling AXS Universal Aspiration Tubing because the label displays an incorrect expiration date of 2023-07-24 instead of 2021-07-24.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for cosmetic defects or documentation issues.
Plain-English summary
Medela AG Medical Technology is recalling 6,244 units of Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing. The recall is due to an incorrect expiration date printed on the label of the sterile tubing. The label displays an expiration date of 2023-07-24, but the correct expiration date is 2021-07-24.
The affected product is used with the Dominant Flex Surgical Suction Pump. The recall covers units distributed worldwide, including nationwide distribution in the United States across states such as AR, AZ, CA, FL, GA, IL, MA, MI, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WV, as well as distribution in the Netherlands. The specific lot number for the recalled units is W-024423.
Healthcare facilities and consumers should check their inventory for this specific product and lot number. If the product is found, it should be removed from use and returned to the supplier or manufacturer according to their instructions.
The recalled product
- 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.
- Manufacturer
- Medela AG Medical Technology
- Hazard
- Affected units
- 6,244
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423
Distribution
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