Medline Incision and Drainage Tray Kits Recalled for Subpotent Iodine
Medline Industries is recalling sterile incision and drainage tray kits because the povidone-iodine prep pads contain less iodine than labeled.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (subpotent antiseptic) are rated as Severe (4), as they are not Class I but involve a significant deviation from label claims.
Plain-English summary
Medline Industries, Inc. is recalling 60 cases of sterile, single-use Incision and Drainage Tray Kits. The recall is due to a subpotent drug issue where the titratable iodine in the included povidone-iodine prep pads is below the label claim of 0.85%.
The affected products are identified by Pack Number DYNDD1039 and Lots 17GB4725 and 17HB4905. These kits were packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The 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 these specific kits and contact Medline Industries for further instructions or a refund. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 60
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: DYNDD1039
- Lots: 17GB4725
- 17HB4905
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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