Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
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; however, given the lack of reported injuries in the text, it falls under the 'Severe' category for Class II recalls involving significant potential harm or specific agency classifications that warrant higher attention than 'High'.
Plain-English summary
Medline Industries, Inc. is recalling 3,800 cases of Medline Suture Removal Trays, Sterile, Single Use Only. The recall involves specific pack numbers DYNDR1111 and DYNDR1112A, and lots 17FB1191, 17HB1905, 177B0660, and 175B2485.
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. Healthcare facilities and consumers should stop using these specific lots and contact Medline Industries for further instructions.
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
- 3,800
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 (5)
- Pack Number: DYNDR1111
- Lots: 17FB1191
- 17HB1905 Pack Number: DYNDR1112A
- Lots 177B0660
- 175B2485
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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