The Recall Desk
SevereFDA (Drugs)·D-0262-2018·Announced 2018-02-07

Medline Trunk Kit Recalled for Subpotent Povidone-Iodine Concentration

Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

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, which corresponds to a Severe rating (Score 4) under the rubric, particularly given the subpotent nature of the antiseptic agent.

Plain-English summary

Medline Industries, Inc. is recalling 231 cases of Medline Trunk Kit, Non-sterile. The product is packaged in the USA for Medline Industries, Inc., located in Mundelein, IL. The recall involves specific lots: 17FA0227, 17FA0470, 17FA1431, 17HA0258, and 17HA0259, under Pack Number DYKTRUNK1.

The recall is due to a subpotent drug issue. The titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This means the antiseptic concentration is lower than what is stated on the product label.

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 or a refund.

The recalled product

Product
Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Affected units
231

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 (6)

  • Pack Number: DYKTRUNK1
  • Lots: 17FA0227
  • 17FA0470
  • 17FA1431
  • 17HA0258
  • 17HA0259

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 →