Baxter Healthcare Corporation: Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

Is my product affected?

Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

• UPC 37332414007837

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

What happened

Baxter Healthcare Corporation has recalled approximately 2.36 million Gambro Cartridge Blood Set Prime Line units worldwide due to a potential disconnection of the tubing set. The product is used for single-use hemodialysis treatment with Dialysis Delivery Systems. The recall affects units distributed across the United States in all states, as well as in Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, and Latvia. The recalled product is identified by Product Code 101025 and UDI 37332414007837, with 57 specific lot numbers listed in the recall notice.

If a consumer or healthcare facility has this product, the recall notice does not specify a remedy or next steps for affected users.

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: 2,361,885 units Lot/code info: Product Code: 101025; UDI: 37332414007837; Lot Numbers: 1000200708, 1000203117, 1000203118, 1000203119, 1000203120, 1000203121, 1000205678, 1000205897, 1000205898, 1000205899, 1000205900, 1000205901, 1000206872, 1000206873, 1000206874, 1000208247, 1000208248, 1000208249, 1000208250, 1000210314, 1000210315, 1000210316, 1000210317, 1000210318, 1000210319, 1000210320, 1000211719, 1000211720, 1000211721, 1000211722, 1000211723, 1000211724, 1000215485, 1000215486, 1000215487, 1000215488, 1000215489, 1000215490, 1000217361, 1000217362, 1000217363, 1000217364, 1000218866, 1000218867, 1000218868, 1000218869, 1000218870, 1000218871, 1000220529, 1000220530, 1000220531, 1000220532, 1000223070, 1000223071, 1000223072, 1000223073, 1000223074, 1000225427, 1000225428, 1000225429, 1000225430, 1000225431, 1000226714, 1000226717, 1000229599

Source

Official record: FDA (Device enforcement) ↗

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

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