Baxter MiniCap Dialysis Pouch Packaging Adhesion Defect Recall
Baxter Healthcare is recalling MiniCap dialysis pouches because the paper layer may not be fully adhered to the foil, potentially compromising the protective barrier.
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 classified as FDA Class II, and the defect is a packaging adhesion issue that may compromise the protective barrier, representing a moderate risk without reported injuries.
Plain-English summary
Baxter Healthcare Corp. is recalling 20,940 units of MiniCap with Povidone-Iodine solution (catalog number 5C4466P) used for dialysis. The recall involves specific lot numbers GD894535 and GD894550.
The recall was initiated because the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. This paper layer serves as a protective barrier and helps support the overall packaging integrity.
The affected products were distributed in Arkansas, Tennessee, Missouri, Kansas, Texas, Mississippi, and Alabama. Consumers and healthcare providers should stop using the affected units and contact Baxter Healthcare for instructions on return or replacement.
The recalled product
- Product
- Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 20,940
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)
- Lot Numbers: GD894535
- GD894550
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighBaxter MiniCap with Povidone-Iodine Solution Recalled for Packaging Defects
FDA (Devices) · 2014-07-23
- HighBaxter MiniCap with Povidone-Iodine Solution Recalled for Leaking Pouches
FDA (Devices) · 2013-07-03
- HighBaxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection
FDA (Devices) · 2023-03-15
- HighBaxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects
FDA (Devices) · 2015-03-25
- CriticalBaxter Recalls Dianeal Low Calcium Peritoneal Dialysis Solution Bags
FDA (Drugs) · 2014-10-08
- SevereBaxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk
FDA (Devices) · 2024-11-27