Medline Recalls IV Start Kits With Subpotent Iodine Concentration
Medline Industries is recalling IV Start Kits 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, which corresponds to a Severe severity score under the rubric.
Plain-English summary
Medline Industries Inc is recalling 5,400 cases of Medical Equipment Affiliates IV Start Kits, Sterile, Single Use Only. The recall is due to a subpotent drug issue where the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%.
The affected product is identified by Pack Number DYNDV39010 and Lot 17QB8612. The kits were packaged in Mexico for Medical Equipment Affiliates in Tahlequah, OK. Distribution was 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 check their inventory for the specific pack and lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or Medline Industries Inc according to their instructions.
The recalled product
- Product
- Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — IV Start Kits
- Hazard
- Affected units
- 5,400
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 (2)
- Pack Number: DYNDV39010
- Lots 17QB8612
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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