Medline Catheter Insertion Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling sterile catheter insertion kits because the iodine concentration in the prep pads is below the labeled claim.
What this means for you
Illness, injury, or structural failure has been reported. 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 in sterile medical kits.
Plain-English summary
Medline Industries, Inc. is recalling 4,100 cases of Medline Catheter Insertion Kit, Sterile. The product was packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The recall involves specific lots: 17SB3347, 175B1052, 16JB3251, 16IB2940, and 17CB4925, with pack number DYNDINSERTKIT.
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 providers should check their inventory for the listed lot numbers and stop using the product if it matches the recall criteria.
The recalled product
- Product
- Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Catheter Kits
- Affected units
- 4,100
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 (6)
- Pack Number: DYNDINSERTKIT
- Lots: 17SB3347
- 175B1052
- 16JB3251
- 16IB2940
- 17CB4925
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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