Home / Recalls / Baxter Healthcare Corporation / Z-1280-2021

Z-1280-2021 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-1280-2021 was initiated by Baxter Healthcare Corporation on Jan 28, 2021 and is designated Class II. Reason for recall: Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test. The recall status is terminated (terminated Jun 13, 2024). Affected quantity: 35175 kits.

Recall details

Product Type: Devices
Report Date: Mar 31, 2021
Initiation Date: Jan 28, 2021
Termination Date: Jun 13, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35175 kits

Product description

Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

Reason for recall

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

Distribution pattern

Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Malta, Mauritius, Montenegro, Morocco, Netherlands, Nigeria, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Syria, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Yemen, Australia, New Zealand, China, Japan, Korea, Taiwan, Hong Kong, India, Thailand, Singapore, Malaysia, Vietnam, Grand Cayman, Dominican Republic, St. Kitts, Venezuela, Argentina, Chile, Barbados, Bermuda, Costa Rica, Cuba, Haiti, Guatemala, Colombia, Trinidad & Tobago, Mexico, and Brazil.

Code information

all serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1280-2021
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Baxter Healthcare Corporation

Z-0151-2027 Class II — Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL… (Sep 14, 2026)
Z-3263-2026 Class II — PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses… (Aug 18, 2026)
Z-3264-2026 Class II — PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses… (Aug 18, 2026)
Z-3262-2026 Class II — PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology… (Aug 18, 2026)
D-0850-2026 Class I — Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare… (Aug 17, 2026)
D-0849-2026 Class I — 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24… (Aug 17, 2026)
Z-3065-2026 Class II — Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS (Aug 11, 2026)
Z-3066-2026 Class II — Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL (Aug 11, 2026)
D-0817-2026 Class II — Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50… (Aug 6, 2026)
D-0806-2026 Class II — MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1… (Aug 6, 2026)