Medline Suture Removal Tray Recalled for Subpotent Povidone-Iodine
Medline Industries is recalling suture removal trays because the povidone-iodine prep pads contain less iodine than labeled.
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 injury or property damage (or hospitalization reports, though not explicitly stated here, the structural defect of subpotency in a sterile medical device warrants high caution) aligns with the Severe category, specifically noting that Class II is the floor for significant risks.
Plain-English summary
Medline Industries Inc. is recalling Medline Straight Suture Removal Trays, Sterile, Single Use Only. The recall involves 10,298 cases of the product, which was packaged in Mexico for Medline Industries, Inc., in Mundelein, IL.
The recall was initiated 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 product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
The specific affected items are identified by Pack Number DYNDR1186 with Lots 17EB0360 and 177B1719, and Pack Number DYNDR1186H with Lots 16PB7974 and 17EB0360. Consumers and healthcare providers should stop using these specific lots and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Trays
- Affected units
- 10,298
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 (5)
- Pack Number: DYNDR1186
- Lots: 17EB0360
- 177B1719 Pack Number: DYNDR1186H
- Lots: 16PB7974
- 17EB0360
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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