Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability
Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall, which corresponds to a 'Severe' severity score under the rubric, particularly given the critical nature of the medical device used for renal replacement therapy.
Plain-English summary
Baxter Healthcare Corporation is recalling 35,175 Preventative Maintenance Kits (G5010007) and spare part kits (G5064801 and G5006203) for Prismaflex Control Units. These products are used for Continuous Renal Replacement Therapy (CRRT). The recall covers all serial numbers.
The recall was initiated because 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 agency has classified this as a Class II recall.
The affected products were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam) and numerous international locations. Healthcare facilities and users should stop using the affected kits and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 35,175
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all serial numbers
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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