Medline Recalls Subpotent Povidone-Iodine Prep Pads
Medline Industries is recalling sterile staple remover trays containing subpotent povidone-iodine prep pads. The iodine concentration is below the labeled claim of 0.85%.
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. According to the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving significant injury or property damage reports, or by default for Class II classifications that do not meet the 'Low' or 'Moderate' criteria for minor errors.
Plain-English summary
Medline Industries Inc. is recalling 248 cases of Medline Staple Remover Tray, Sterile, Single Use Only. The product is packaged in the USA for Medline Industries, Inc., located in Northfield, IL. The recall involves specific pack numbers DYNDR1067 and DYNDR1067H, both associated with lot number 17PB4605.
The recall is due to a subpotent drug issue. The titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This means the active ingredient concentration is lower than what is stated on the product label.
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. Consumers and healthcare facilities should stop using the affected products and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Topical Antiseptic
- Affected units
- 248
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: DYNDR1067
- Lots: 17PB4605 Pack Number: DYNDR1067H
- Lots: 17PB4605
Distribution
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.
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