Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 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, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are explicitly reported, the subpotent nature of a sterile surgical product in a Class II recall warrants a Severe rating under the 'never go below 4' rule for Class I/II contexts where significant risk is implied by the classification.
Plain-English summary
Medline Industries, Inc. is recalling 346 cases of Medline NICC Suture Removal Trays, Sterile, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL.
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. The specific pack numbers are DYNDR1161 and DYNDR1161H, with lot number 17RB9449. Consumers and healthcare providers should stop using these products and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 346
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: DYNDR1161
- Lots: 17RB9449 Pack Number: DYNDR1161H
- Lots: 17RB9449
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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