The Recall Desk
SevereFDA (Drugs)·D-0266-2018·Announced 2018-02-07

Medline Central Line Dressing Change Tray Kit Recalled for Subpotent Iodine

Medline is recalling Central Line Dressing Change Tray Kits because the iodine concentration in the prep pads is below the label claim.

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, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or hospitalization reports are Severe. While no specific injuries are reported in the text, the subpotent nature of a sterile medical device used for central line care presents a significant risk of infection, aligning with the Severe criteria for Class II recalls involving significant potential harm.

Plain-English summary

Medline Industries, Inc. is recalling 14,675 cases of Medline Central Line Dressing Change Tray Kits, Sterile, Single use only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL.

The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This subpotent condition means the antiseptic may not be as effective as stated on the packaging.

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. Specific lot numbers and pack numbers are listed in the structured product information. Healthcare facilities and consumers should stop using the affected lots and contact Medline for further instructions.

The recalled product

Product
Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Manufacturer
Medline Industries Inc
Category
Medical Device — Sterile Dressing / Prep Kit
Hazard
Affected units
14,675

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 (16)

  • Pack Number: DYND74661
  • Lots: 177B1602
  • 17RB9139
  • 16WB5199
  • 17CB7720
  • 17CB5841
  • 167B0074
  • 16GB8853
  • 16JB0621
  • 17EB4904
  • 16TB9798
  • 165B0465 Pack Number: DYND74661H
  • Lots: 17EB4904
  • 17CB1032
  • 165B0465
  • 177B1602

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 →

Related recalls

Same manufacturer · Medline Industries Inc

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Same hazard · subpotent drug

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