Medline Recalls Suture Removal Kits with Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric.
Plain-English summary
Medline Industries Inc is recalling Professional Hospital Supply Suture Removal Kits, Sterile, Single Use Only. The recall involves 450 cases of the product, which was packaged in Mexico for Professional Hospital Supply, Inc.
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 product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The specific pack number is P524151, and the affected lots are 17HB5103 and 17RB8741. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Hazard
- Affected units
- 450
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: P524151
- Lots 17HB5103
- 17RB8741
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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