Z-1278-2021 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-1278-2021 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: 1225 units.

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
1225 units

Product description

Prismaflex Control Unit - Product Usage: 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

GTIN 07332414105266 (product code 11308), serial numbers PA9946, PA9945, PA9939, PA9938, PA9936, PA9935, PA9934, PA9933, PA9932, PA9931, PA9930, PA9929, PA9928, PA9926, PA9925, PA9924, PA9923, PA9922, PA9921, PA9920, PA9919, PA9918, PA9917, PA9916, PA9915, PA9914, PA9913, PA9912, PA9907, PA9813, PA9804, PA9803, PA9801, PA9800, PA9799, PA9798, PA9797, PA9796, PA9793, PA9792, PA9791, PA9786, PA9784, PA9724, PA9723, PA9714, PA9713, PA9712, PA9711, PA9709, PA9703, PA9680, PA9675, PA9674, PA9669, PA9668, PA9667, PA9666, PA9665, PA9664, PA9663, PA9662, PA9661, PA9660, PA9659, PA9658, PA9657, PA9656, PA9655, PA9654, PA9653, PA9646, PA9606, PA9605, PA9604, PA9603, PA9601, PA9600, PA9599, PA9598, PA9597, PA9595, PA9594, PA9593, PA9592, PA9591, PA9590, PA9589, PA9586, PA9585, PA9582, PA9581, PA9579, PA9238, PA9216, PA9215, PA9213, PA9209, PA9208, PA9205, PA9204, PA9201, PA9199, PA9141, PA9128, PA9122, PA9121, PA9120, PA9119, PA9117, PA9114, PA9061, PA9039, PA9032, PA9028, PA9027, PA9026, PA9025, 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Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1278-2021
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.

Source: openFDA record for Z-1278-2021. Report a data issue: hello@regdatalab.com.