Agency classClass IIOur severity:Severe FDA (Drugs)·D-0278-2018·Announced 2018-02-07

Medline Povidone-Iodine Prep Pads Recalled for Subpotent Iodine Content

Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 potential for significant health consequences (such as subpotent antiseptic agents) are rated as Severe (4).

Plain-English summary

Medline Industries Inc. is recalling Medline General Purpose Tray, Sterile, Single Use Only, which contains Povidone-Iodine prep pads. The recall was initiated because the titratable iodine contained in the pads is below the label claim of 0.85%.

The affected product is packaged in the USA for Medline Industries, Inc., located in Mundelein, IL. The recall involves 56 cases with Pack Number DYNDL1648 and Lot 17FA0144. Distribution was 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 for further instructions or a refund. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Manufacturer: Medline Industries Inc
Category: Medical Device — Surgical Prep Pads
Hazard: subpotent-drug
infection-risk
Affected units: 56

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: DYNDL1648
Lots: 17FA0144

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 →

Same manufacturer · Medline Industries Inc

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