The Recall Desk
SevereFDA (Drugs)·D-0281-2018·Announced 2018-02-07

Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

Medline is recalling 1,100 cases of GHS Suture Removal Trays because the iodine concentration 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, which corresponds to a Severe rating under the rubric.

Plain-English summary

Medline Industries Inc. is recalling 1,100 cases of Medline GHS Suture Removal 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 product is identified by Pack Number DYNDR1056 and Lot 17RB9450. The product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.

Consumers and healthcare facilities should stop using the affected product and contact Medline Industries Inc. for further instructions or a refund.

The recalled product

Product
Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Affected units
1,100

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: DYNDR1056
  • Lots: 17RB9450

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 →