Baxter Prismaflex System Recall for Connector Safety Information
Baxter is recalling 1,225 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a Class II recall involving the communication of safety information regarding proper use, which fits the criteria for moderate severity as it involves a potential risk of harm but is primarily informational.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,225 units of the Prismaflex System, Prismaflex Control Unit. The recall is being conducted to communicate safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the system.
The affected products were distributed in the US and Puerto Rico. The product code is 113081 and the GTIN is 07332414105266.
Consumers and healthcare providers should refer to the Prismaflex Operator's Manual for the proper use of connectors with the Prismaflex system.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,225
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 (2)
- Product Code: 113081
- GTIN 07332414105266
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · misuse
See all →- ModerateG & H Wire Company Recalls Orthodontic Elastic Bands Due to Labeling Error
FDA (Devices) · 2021-03-10
- HighConfirm Biosciences Recalls Orient Gene COVID-19 Rapid Test Cassettes
FDA (Devices) · 2021-02-24
- ModerateBaxter Prismaflex System Recall for Connector Usage Safety Information
FDA (Devices) · 2020-05-06
- ModerateMedtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions
FDA (Devices) · 2019-02-13
- HighLife Technologies Recalls Oncomine Dx Target Test User Guides
FDA (Devices) · 2018-04-11
Similar recalls
- SevereBaxter Prismaflex Control Unit Recalled for Communication Error Alarms
FDA (Devices) · 2019-11-13
- SevereBaxter Prismaflex Control Unit Recalled for Potential Therapy Interruption
FDA (Devices) · 2019-11-13
- ModerateBaxter Recalls Prismaflex Control Units Lacking FDA Clearance
FDA (Devices) · 2020-05-27
- SevereBaxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk
FDA (Devices) · 2019-11-13
- HighBaxter Recalls Prismaflex Control Units Due to Tubing Performance Variability
FDA (Devices) · 2021-03-31
- HighBaxter Recalls Prismaflex Control Units Due to Software and Usage Issues
FDA (Devices) · 2018-04-11