Medline Circumcision Tray Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Circumcision Tray Kits because the iodine concentration 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, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects are rated as Severe (4).
Plain-English summary
Medline Industries, Inc. is recalling 80 cases of Medline Circumcision Tray Kits, Sterile, Single use only. The product is packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. The specific pack number is DYNDF1012E and the lot number is 17SB5574.
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 these specific kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
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: DYNDF1012E
- Lots: 17SB5574
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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