Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 9,000 cases of Suture Removal Trays because the iodine concentration in the prep pads is below the labeled 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving subpotent drug components that may impact efficacy.
Plain-English summary
Medline Industries, Inc. is recalling 9,000 cases of Medline Suture Removal Trays, Sterile, Single Use Only. The recall involves Pack Number SD-1010 and Lots 17CB8694, 17MB4778, and 16KB5621. The product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
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 FDA has classified this recall as Class II.
Healthcare facilities and consumers should stop using the affected suture removal trays and contact Medline Industries for instructions on return or replacement. Users should verify the pack number and lot numbers against the recall list to determine if their inventory is affected.
The recalled product
- Product
- Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 9,000
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: SD-1010
- Lots 17CB8694
- 17MB4778
- 16KB5621
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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