Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Trays because the iodine concentration is below the labeled 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury or property damage reports or structural defects, though here it is driven by the agency's explicit Class II designation for a subpotent drug.
Plain-English summary
Medline Industries, Inc. is recalling 3,089 cases of Medline Suture Removal Tray, Sterile, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL.
The recall is due to a subpotent drug issue where the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. The affected products are identified by Pack Number DYNDR1157 with Lot 177B0661, and Pack Number DYNDR1157H with Lots 177B0661 and 17QB1693.
The products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Surgical Supplies
- Affected units
- 3,089
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 (4)
- Pack Number: DYNDR1157
- Lots: 177B0661 Pack Number: DYNDR1157H
- Lots: 177B0661
- 17QB1693
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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