FDA Device recall Z-1278-2021

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT)

FDA Device
Class II
terminated
Published 2021-03-31

On 2021-03-31 the FDA classified a Class II recall of Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT) by Baxter Healthcare, citing 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 sys….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1278-2021
Classification	Class II
Status	terminated
Initiated	2021-01-28
Published	2021-03-31
Last updated	2026-09-13 11:56 UTC
Company	Baxter Healthcare
Distribution	US

Product

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

Reason

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.

Identifiers

code_info	GTIN 07332414105266 (product code 11308), serial numbers PA9946, PA9945, PA9939, PA9938, PA9936, PA9935, PA9934, PA9933… 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,

code_info

GTIN 07332414105266 (product code 11308), serial numbers PA9946, PA9945, PA9939, PA9938, PA9936, PA9935, PA9934, PA9933…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1278-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.