The Recall Desk
ModerateFDA (Devices)·Z-1945-2014·Announced 2014-07-09

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.

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 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.
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

Distributed in 7 states: