Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
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 score of 4 (Severe), particularly when involving subpotent drug components where efficacy is compromised.
Plain-English summary
Medline Industries Inc. is recalling Medline Suture Removal Trays, Sterile, Single Use Only. The recall involves 49,587 cases of the product, which was distributed nationwide in the United States as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
The recall is being conducted 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 are identified by Pack Numbers MDS701550 and MDS701550H, along with specific lot numbers listed in the recall documentation.
Healthcare providers and consumers should stop using the affected suture removal trays and contact Medline Industries Inc. for further instructions or a refund. The product was packaged in Mexico by Medline Industries, Inc., located in Mundelein, IL.
The recalled product
- Product
- Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 49,587
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 (13)
- Pack Number: MDS701550
- Lots 16GB7687
- 17HB5153
- 16IB0427
- 17GB3906
- 17AB1937
- 17CB7737
- 16JB1136
- 16JB1137 Pack Number: MDS701550H
- Lots 16QB4583
- 16MB6165
- 16GB7687
- 16JB1137
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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