Medline Incision and Drainage Tray Recalled for Subpotent Iodine
Medline is recalling sterile incision and drainage trays 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 rating under the rubric for drug recalls involving subpotent active ingredients.
Plain-English summary
Medline Industries Inc. is recalling 808 cases of Medline Incision and Drainage Tray, Sterile, Single Use Only. The product was packaged in Mexico by Medline Industries, Inc., in Mundelein, IL.
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 products are identified by Pack Number MDS70815 with Lots 16LB2959, 173B1289, 17HB4108, 17FB6679, and 16JB8627, as well as Pack Number MDS70815H with Lot 17FB6679.
The products were distributed nationwide in the USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. Consumers and healthcare providers should check their inventory for these specific lot and pack numbers and stop using the affected trays if found.
The recalled product
- Product
- Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Hazard
- Affected units
- 808
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 (7)
- Pack Number: MDS70815
- Lots 16LB2959
- 173B1289
- 17HB4108
- 17FB6679
- 16JB8627 Pack Number: MDS70815H
- Lots 17FB6679
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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