Medline Laceration Tray Recalled for Subpotent Povidone-Iodine Concentration
Medline Industries is recalling 600 cases of Laceration Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
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, an FDA Class II recall is assigned a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Medline Industries, Inc. is recalling 600 cases of Medline Laceration Trays, Sterile, Single Use Only. The product is identified by Pack Number DYNDL1688 and Lot 17HB3112. The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%.
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. 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.
Consumers and healthcare facilities should stop using the affected Laceration Trays and contact Medline Industries for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Affected units
- 600
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: DYNDL1688
- Lots: 17HB3112
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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