Medline Suture Removal Packs Recalled for Subpotent Iodine Content
Medline Industries is recalling Suture Removal Packs because the iodine content is below the label claim of 0.85%.
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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the subpotent nature of the antiseptic agent.
Plain-English summary
Medline Industries Inc. is recalling Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. The recall involves 663 cases of the product, which was packaged in Mexico for Medline Industries, Inc., located in Northfield, IL.
The recall is due to a subpotent drug issue where the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. The affected product is identified by Pack Number P734457 and Lots 17GB5158, 17RB8681, and 17FB0926.
The product was 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 the affected lots and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Affected units
- 663
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 (4)
- Pack Number: P734457
- Lots 17GB5158
- 17RB8681
- 17FB0926
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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