Agency classClass IIOur severity:Severe FDA (Drugs)·D-0295-2018·Announced 2018-02-07

Medline Recalls Povidone-Iodine Prep Pads Due to Subpotent Iodine Levels

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, which corresponds to a Severe rating under the rubric, particularly given the subpotent nature of the antiseptic agent in a sterile medical context.

Plain-English summary

Medline Industries, Inc. is recalling 3,300 cases of Medline General Purpose Instrument Set, Sterile, Single Use Only. The specific issue involves the Povidone-Iodine prep pads contained in these sets, where the titratable iodine content is below the label claim of 0.85%.

The affected products were packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The recall includes items with Pack Number DYNDS1014 and Lots 17GB3416 and 176B2045.

Distribution was nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. Users should stop using the affected prep pads and contact Medline Industries for further instructions.

The recalled product

Product: Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Manufacturer: Medline Industries Inc
Category: Medical Device — Surgical Instruments
Hazard: subpotent-drug
infection-risk
Affected units: 3,300

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: DYNDS1014
Lots 17GB3416
176B2045

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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