Medline Skin Stapler RMVR Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Skin Stapler RMVR 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 affect efficacy.
Plain-English summary
Medline Industries, Inc. is recalling 592 cases of Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. The product was packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The recall involves Pack Number P888937 (Lots 177B0658; 17QB8268) and Pack Number P888937H (Lots 17QB8268).
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 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 facilities should stop using the affected lots and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 592
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: P888937
- Lots 177B0658
- 17QB8268 Pack Number: P888937H
- Lots 17QB8268
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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