The Recall Desk
ModerateFDA (Drugs)·D-0315-2018·Announced 2018-02-07

Medline Incision Drainage Tray Recalled for Subpotent Iodine Concentration

Medline Industries is recalling specific lots of Incision Drainage Trays because the iodine concentration is below the label claim.

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 hazard involves a subpotent antiseptic agent without reported illnesses or injuries, fitting the criteria for a moderate severity rating.

Plain-English summary

Medline Industries, Inc. is recalling specific lots of Medline Incision Drainage Trays, Sterile, Single Use Only. The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%.

The affected products are Pack Number P888943 (Lots 17RB8662) and Pack Number P888937H (Lots 17QB8268). These products were distributed nationwide in the United States, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.

Consumers and healthcare providers should check their inventory for the specific pack numbers and lot numbers listed above. If the products are found, they should be removed from use and returned to the supplier or the recalling firm.

The recalled product

Product
Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

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 (3)

  • Pack Number: P888943
  • Lots 17RB8662 Pack Number: P888937H
  • Lots 17QB8268

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 →