Baxter MiniCap with Povidone-Iodine Solution Recalled for Packaging Defects
Baxter Healthcare is recalling 585,360 units of MiniCap with Povidone-Iodine Solution due to inadequate iodine and packaging defects.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no hospitalizations or serious injuries are explicitly reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 585,360 units of Baxter MiniCap with Povidone-Iodine Solution, catalog number 5C4466P. The product is used for dialysis and was distributed nationwide in the United States and in Canada.
The recall was initiated due to inadequate iodine levels and packaging-related defects. The agency classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
Consumers and healthcare facilities should stop using the affected units and contact Baxter Healthcare Corporation for instructions on return or replacement. The specific lot code associated with this recall is GD895771.
The recalled product
- Product
- Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 585,360
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)
- GD895771
Distribution
Distributed nationwide across the United States.
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