Medline Suture Removal Tray Recalled for Subpotent Iodine Content
Medline Industries is recalling Suture Removal Trays because the iodine content in the prep pads 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 agency classification is FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a subpotent drug where the active ingredient is below the labeled claim.
Plain-English summary
Medline Industries, Inc. is recalling 100 cases of Medline Suture Removal Trays, Sterile, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The specific product is identified by Pack Number DYNDR1195 and Lot 17AB1899.
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 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 providers should stop using the affected lots and contact Medline Industries for further instructions.
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
- 100
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: DYNDR1195
- Lots: 17AB1899
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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