Baxter Prismaflex System Safety Communication on Connector Use
Baxter issued a safety communication regarding the proper use of connectors with the Prismaflex System and Control Unit.
What this means for you
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 source describes a safety communication regarding proper use rather than a defect causing injury, fitting the criteria for a voluntary precautionary recall or minor labeling/instruction issue.
Plain-English summary
Baxter Healthcare Corporation is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. This action involves the Prismaflex System and Prismaflex Control Unit.
The recall number for this action is Z-1830-2020. The agency classification is Class II. The distribution pattern includes the US and Puerto Rico.
Users should refer to the Prismaflex Operator's Manual for proper connector usage instructions.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 2,471
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: 114870
- GTIN 07332414115395
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 →- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighBaxter Head Positioning Adapter May Loosen During Patient Positioning
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · improper use
See all →- ModerateGenius Review Station Display Modified Outside Validated Configuration
FDA (Devices) · 2026-05-06
- HighChannelCheck Convenience Pack Pre-filled Water Syringes Recalled
FDA (Devices) · 2025-06-11
- ModeratePre-filled Water Syringe recalled for improper use contamination
FDA (Devices) · 2025-06-11
- HighBD Connecta Stopcocks Recalled for Non-U.S. Instructions Shipped to U.S. Market
FDA (Devices) · 2025-04-09
- ModerateAlcon anti-reflux valve tubing breakage recall due to improper use
FDA (Devices) · 2024-11-27