The Recall Desk
SevereFDA (Drugs)·D-0258-2018·Announced 2018-02-07

Medline Concordia Trunk Kit Recalled for Subpotent Iodine Concentration

Medline Industries is recalling Concordia Trunk Kits because the povidone-iodine prep pads contain less iodine than the label claims.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant product defects like subpotent active ingredients.

Plain-English summary

Medline Industries, Inc. is recalling 21 cases of Medline Concordia Trunk Kits. The product is packaged for Medline Industries, Inc., located in Northfield, IL. The specific pack number is DYKM1403 and the lot number is 17BA1782.

The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This is classified as a subpotent drug issue.

The affected products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. Consumers and healthcare providers should stop using the affected lots and contact Medline Industries for further instructions.

The recalled product

Product
Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Affected units
21

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)

  • Pack Number: DYKM1403
  • Lots: 17BA1782

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 68 products in this recall →