Medline Incision and Drainage Tray Kit Recalled for Subpotent Iodine
Medline is recalling Incision and Drainage Tray Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
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 according to the rubric.
Plain-English summary
Medline Industries Inc is recalling 11 cases of Medline Incision and Drainage Tray Kits, Sterile, Single use only. The recall is due to a subpotent drug issue where the titratable iodine in the Povidone-Iodine prep pads is below the label claim of 0.85%.
The affected product is identified by Pack Number DYNDA1046H and Lot 16LA0907. The product was 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 check their inventory for the specific pack and lot numbers listed. If the product is found, it should be removed from use and returned to the supplier or Medline Industries Inc for credit or replacement.
The recalled product
- Product
- Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 11
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: DYNDA1046H
- Lots: 16LA0907
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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