Medline Recalls Subpotent Povidone-Iodine Prep Pads in Hip Replacement Kits
Medline Industries is recalling hip replacement kits containing Povidone-Iodine prep pads with iodine levels below the label claim of 0.85%.
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 mapped to a severity score of 4 (Severe), particularly given the subpotent nature of the antiseptic agent in a surgical context.
Plain-English summary
Medline Industries Inc. is recalling 88 cases of Medline Hip Replacement, Kit, Sterile, Single Use Only. The kits were packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093. The specific lots affected are 17FB2504 and 17HB2544, with Pack Number DYNJ48244B.
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 FDA has classified this recall as Class II.
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 the affected lots and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 88
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 (3)
- Pack Number: DYNJ48244B
- Lots 17FB2504
- 17HB2544
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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