Medline DC Line Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling DC Line 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 score of 4 (Severe), particularly when involving subpotent drugs where efficacy is compromised.
Plain-English summary
Medline Industries, Inc. is recalling 363 cases of Medline DC Line Kits, Sterile, Single use only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The recall involves specific pack numbers and lots: Pack Number DYNDC1971 with Lot 175B1999, and Pack Number DYNDC1971H with Lots 17OB8570 and 175B1999.
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 or a refund. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic / Topical
- Affected units
- 363
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: DYNDC1971
- Lots: 175B1999
- Pack Number: DYNDC1971H
- Lots: 17OB8570
- 175B1999
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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