Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving subpotent drugs where efficacy is compromised.
Plain-English summary
Medline Industries, Inc. is recalling 700 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 lots affected are 15HB6327 and 15HB4355, with Pack Number DYNDR1165.
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 agency classification for this recall is Class II.
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 check their inventory for the specific lot numbers and pack number listed above and stop using the product if it matches the recall criteria.
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
- 700
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 (3)
- Pack Number:DYNDR1165
- Lots: 15HB6327
- 15HB4355
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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