The Recall Desk
SevereFDA (Drugs)·D-0307-2018·Announced 2018-02-07

Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

Medline is recalling Suture Removal Trays 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving subpotent drug components where efficacy is compromised.

Plain-English summary

Medline Industries Inc. is recalling Medline Suture Removal Trays, Sterile, Single Use Only. The recall involves 49,587 cases of the product, which was distributed nationwide in the United States as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.

The recall is being conducted 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 are identified by Pack Numbers MDS701550 and MDS701550H, along with specific lot numbers listed in the recall documentation.

Healthcare providers and consumers should stop using the affected suture removal trays and contact Medline Industries Inc. for further instructions or a refund. The product was packaged in Mexico by Medline Industries, Inc., located in Mundelein, IL.

The recalled product

Product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Manufacturer
Medline Industries Inc
Category
Medical Device — Surgical Supplies
Hazard
Affected units
49,587

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 (13)

  • Pack Number: MDS701550
  • Lots 16GB7687
  • 17HB5153
  • 16IB0427
  • 17GB3906
  • 17AB1937
  • 17CB7737
  • 16JB1136
  • 16JB1137 Pack Number: MDS701550H
  • Lots 16QB4583
  • 16MB6165
  • 16GB7687
  • 16JB1137

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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