FDAClass IIMarch 25, 2015

MiniCap with Povidone-Iodine Solution recall

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

Why was MiniCap with Povidone-Iodine Solution recalled?

Product may have separating or protruding sponges

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015

Product
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Recalling firm
Baxter Healthcare Corp.
Quantity
4,391,520 units
Distribution
Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
Recall date
March 25, 2015
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls