Home / Recalls / Baxter Healthcare Corporation / Z-2193-2020

Z-2193-2020 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-2193-2020 was initiated by Baxter Healthcare Corporation on April 17, 2020 and is designated Class II. Reason for recall: Potential disconnection of tubing set. The recall status is terminated (terminated February 7, 2023). Affected quantity: 2,361,885 units.

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
April 17, 2020
Termination Date
February 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,361,885 units

Product Description

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

Reason for Recall

Potential disconnection of tubing set.

Distribution Pattern

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, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong

Code Information

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

Other recalls by Baxter Healthcare Corporation

  • Z-2766-2026 Class I — Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; So (June 30, 2026)
  • Z-2548-2026 Class I — Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog (May 21, 2026)
  • Z-2551-2026 Class I — Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat (May 21, 2026)
  • Z-2550-2026 Class I — Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal (May 21, 2026)
  • Z-2549-2026 Class I — Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog (May 21, 2026)
  • Z-2262-2026 Class II — Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog N (April 22, 2026)
  • Z-2638-2026 Class II — Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun (April 21, 2026)
  • Z-1637-2026 Class I — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. (February 18, 2026)
  • Z-1573-2026 Class II — Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS (February 18, 2026)
  • Z-1368-2026 Class II — Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570 (January 13, 2026)

FDA data resources