Baxter Healthcare Corporation: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Di

Is my product affected?

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

• UPC 37332414112401

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

What happened

Baxter Healthcare Corporation is recalling 4,065 units of its Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set due to a potential disconnection of the tubing set during use. The affected product has specific lot numbers (1000212228, 1000215484, and 1000224531) and was distributed worldwide, including throughout the United States and multiple international countries such as Canada, Australia, and several European nations.

The recall affects single-use blood sets intended for hemodialysis treatment. The source document does not specify what actions affected consumers should take in response to this recall.

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

Hazard

Potential disconnection of tubing set.

Details from the source

Reason for recall: Potential disconnection of tubing set. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia Quantity: 4,065 Lot/code info: Product Code: 114435; UDI: 37332414112401; Lot Numbers: 1000212228, 1000215484, 1000224531

Source

Official record: FDA (Device enforcement) ↗

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

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